No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00647529004005 | Diode Laser Tips - Starter Kit | 6400165 | An assortment kit containing a combination of uninitiated and pre-initiated lase An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns and different lenghts. The tips are non-sterile for single use only and require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
2 | 00647529003534 | 7210001 | 7210001 | An all-tissue dental laser system intended for a variety of oral soft-tissue and An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a wireless footswitch and a delivery system comprising of a fiber optic cable, two handpieces and a variety of laser tips. Other system components include protective eyewear, power cords, a tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Express All-Tissue Laser System |
3 | 00647529003411 | Pre-initiated Surgical Assortment | 6400564 | An assortment kit containing 30 single-use pre-initiated tips intended for use w An assortment kit containing 30 single-use pre-initiated tips intended for use with Biolase diode laser delivery systems. The tips vary in length and core diameter. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
4 | 00647529003237 | EZ Tips, Starter Kit | 6400604 | A tip kit containing 10 single-use, non-initiated laser tips intended for use wi A tip kit containing 10 single-use, non-initiated laser tips intended for use with Biolase diode laser delivery systems. The tips have the same length of 4mm and vary in core diameter. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
5 | 00647529002728 | 6400310 | 6400310 | Disposable shields are single-use, non-sterile, clear plastic protective covers Disposable shields are single-use, non-sterile, clear plastic protective covers intended for and specifically designed for use with the Biolase Deep Tissue Handpiece during pain therapy procedures. The disposable shields must be discarded after one-time use to avoid cross-contamination between patients. | MMP | Cover, Barrier, Protective | Deep Tissue Handpiece Disposable Shields | |
6 | 00647529002711 | 6400180 | 6400180 | Disposable shields are single-use, non-sterile, clear plastic protective covers Disposable shields are single-use, non-sterile, clear plastic protective covers intended for and specifically designed for use with the Biolase Whitening Handpiece during tooth whitening procedures. The disposable shields fit over the head of the Handpiece and must be discarded after one-time use to avoid cross-contamination between patients. | MMP | Cover, Barrier, Protective | Whitening Handpiece Disposable Shields | |
7 | 00647529002513 | 7200861-06 Refurbished | An all-tissue dental laser system intended for a variety of soft-tissue and hard An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase MDX 300 Laser System | |
8 | 00647529002506 | 7200860-06 Refurbished | An all-tissue dental laser system intended for a variety of soft-tissue and hard An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase MDX 450 Laser System | |
9 | 00647529002490 | 7200401 Refurbished | An all-tissue dental laser system intended for a variety of soft-tissue and hard An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase MD Turbo Laser System | |
10 | 00647529001967 | EpiTips Surgical Assortment | 6400564 | An assortment kit containing 30 single-use pre-initiated tips intended for use w An assortment kit containing 30 single-use pre-initiated tips intended for use with diode laser delivery systems. The tips vary in length and core diameter. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
11 | 00647529002339 | 7210001 | 7210001 | An all-tissue dental laser system intended for a variety of soft-tissue and hard An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, and a wireless foot-switch. Other system components include protective eyewear, power cords, tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Express All-Tissue Laser System |
12 | 00647529001554 | 7200401 | 7200401 | An all-tissue dental laser system intended for a variety of soft-tissue and hard An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase MD Turbo Laser System |
13 | 00647529000304 | 7200860-06 | 7200860-06 | An all-tissue dental laser system intended for a variety of soft-tissue and hard An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase MDX 450 Laser System |
14 | 00647529000298 | 7200861-06 | 7200861-06 | An all-tissue dental laser system intended for a variety of soft-tissue and hard An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase MDX 300 Laser System |
15 | 00647529000113 | laserwhite20 | 7400030 | laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers. | LBH | Varnish, Cavity | laserwhite20 Whitening Gel | |
16 | 00647529003718 | 7220003 | 7220003 | A reusable handpiece intended for use with Waterlase laser systems in a variety A reusable handpiece intended for use with Waterlase laser systems in a variety of dental hard-tissue and soft-tissue procedures. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser System Gold Straight Handpiece |
17 | 00647529002551 | iLase Refurbished | iLase Handpiece is a diode laser handpiece designed for a variety of dental soft iLase Handpiece is a diode laser handpiece designed for a variety of dental soft tissue procedures. The packaging contains one handpiece and accessories such as diode laser tips, tip cleaning kit, tip initiation kit and 2 extra handpiece cover grips. iLase charging station is not included. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use. | GEX | Powered Laser Surgical Instrument | 2 | iLase Handpiece | |
18 | 00647529002476 | 7400073 Refurbished | A dental diode laser system intended for a variety of soft-tissue procedures, la A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Epic X Diode Laser System | |
19 | 00647529002469 | 6201126 Refurbished | A reusable handpiece intended for use with Waterlase laser systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser System Turbo Handpiece | |
20 | 00647529002452 | 7400042 Refurbished | A dental diode laser system intended for a variety of soft-tissue procedures, la A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories ( power cord, tip holder, protective eyewear). The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Epic 10 Diode Laser System | |
21 | 00647529002292 | iLase | iLase is a small, lightweight, battery-operated diode laser handpiece intended f iLase is a small, lightweight, battery-operated diode laser handpiece intended for a variety of dental soft-tissue procedures such as incision, excision, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva, as well as laser periodontal procedures. The laser has a wavelength of 940nm. The laser energy is delivered to the treatment site via a single-use laser tip attached to the handpiece.The handpiece is reusable with a removable cover which requires sterilization prior to each patient use. The iLase packaging contains one handpiece and accessories such as laser tips, tip cleaning kit, tip initiation kit and 2 extra handpiece cover grips.The product is also available as a system packaged with a charging station which is used for charging and storing the iLase and replacement batteries. | GEX | Powered Laser Surgical Instrument | 2 | iLase Handpiece | |
22 | 00647529002285 | 6201126 | 6201126 | A reusable handpiece intended for use with Waterlase laser systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser System Turbo Handpiece |
23 | 00647529000175 | 7400073 | 7400073 | A surgical and therapeutic device intended for a variety of soft-tissue procedur A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, tip holders, protective eyewear, screen protectors). The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Epic X Diode Laser System |
24 | 00647529000168 | 7400042 | 7400042 | A surgical and therapeutic device intended for a variety of soft-tissue procedur A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use. | GEX | Powered Laser Surgical Instrument | 2 | Epic 10 Diode Laser System |
25 | 00647529002520 | 7400022 Refurbished | A reusable hand-held device intended for use with Diode Laser Systems in tooth w A reusable hand-held device intended for use with Diode Laser Systems in tooth whitening procedures. The device is used with disposable protective shields. | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Diode Laser System Whitening Handpiece | |
26 | 00647529000205 | 7400022 | 7400022 | Whitening Handpiece is intended for use with Biolase diode laser systems such as Whitening Handpiece is intended for use with Biolase diode laser systems such as Epic X or Epic Pro and LaserWhite20 Whitening Gel for laser-assisted tooth whitening procedures. The handpiece is reusable and requires disinfection prior to use. The handpiece is equipped with with single-use disposable protective shields included in the packaging in a set of 5. | GEX | Powered Laser Surgical Instrument | Diode Laser System Whitening Handpiece | |
27 | 00647529003305 | Pre-Initiated, Perio, 3-9 | 7400065 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Bio A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
28 | 00647529003183 | PI Pro Tips, Surgical, 4-4 | 7430002 | A single-use fiberoptic pre-initiated tip intended for use with Epic Pro Diode L A single-use fiberoptic pre-initiated tip intended for use with Epic Pro Diode Laser Systems. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
29 | 00647529003640 | Surgical EZ Tips | 7400053 | A tip kit containing 3 single-use laser tips intended for use with Epic S-Serie A tip kit containing 3 single-use laser tips intended for use with Epic S-Series laser systems. The tips have the same core diameter of 400 microns and vary in length. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
30 | 00647529003503 | Starter Kit | 7200891 | A starter kit containing 14 different laser tips intended for use with Waterlase A starter kit containing 14 different laser tips intended for use with Waterlase laser delivery systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser Tips |
31 | 00647529003343 | Pre-initiated, Surgical, 3-4 | 7400071 | A single-use fiberoptic pre-initiated tip intended for use with diode laser systems. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
32 | 00647529003336 | Pre-Initiated, Perio, 4-9 | 7400069 | A single-use fiberoptic pre-initiated tip intended for use with diode laser systems. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
33 | 00647529003329 | Pre-initiated, Perio, 4-7 | 7400068 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Bio A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
34 | 00647529003312 | Pre-initiated, Surgical, 4-4 | 7400067 | A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Bio A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
35 | 00647529003299 | Pre-initiated, Perio, 3-7 | 7400064 | A single-use fiberoptic pre-initiated tip intended for use with diode laser systems. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
36 | 00647529003220 | PI Pro Tips, Starter Kit | 6400605 | A starter kit containing 10 single-use pre-initiated laser tips intended for use A starter kit containing 10 single-use pre-initiated laser tips intended for use with Epic Pro Diode Laser Systems. The tips have the same length of 4 mm and core diameters of 300 and 400 µm. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
37 | 00647529003176 | PI Pro Tips, Surgical, 3-4 | 7430001 | A single-use fiberoptic pre-initiated tip intended for use with Epic Pro diode l A single-use fiberoptic pre-initiated tip intended for use with Epic Pro diode laser systems. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
38 | 00647529001516 | RFPT8-14 | A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser Tips | |
39 | 00647529002599 | 7400055 Refurbished | A therapeutic laser system intended for use in providing temporary relief of mi A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries. | ILY,GEX | Lamp, Infrared, Therapeutic Heating,Powered Laser Surgical Instrument | 2 | Epic T-Series Diode Laser System | |
40 | 00647529002223 | MZ8-6 ZipTips | A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser Tips | |
41 | 00647529001851 | Surgical EZ Tips | 7400053 | A tip kit containing 2 single-use laser tips intended for use with Epic S-Series A tip kit containing 2 single-use laser tips intended for use with Epic S-Series laser systems. The tips have the same core diameter of 400 microns and vary in length. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
42 | 00647529001820 | Perio EZ Tips Combo Pack, E3 | 7400020 | A tip kit containing 30 single-use laser tips intended for use with Biolase diod A tip kit containing 30 single-use laser tips intended for use with Biolase diode laser systems. The tips have the same core diameter of 300 microns and vary in length. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
43 | 00647529001813 | Perio EZ Tips Combo Pack, E4 | 7400019 | A tip kit containing 30 single-use laser tips intended for use with diode laser A tip kit containing 30 single-use laser tips intended for use with diode laser systems. The tips have the same core diameter of 400 microns and vary in length. | GEX | Powered Laser Surgical Instrument | 2 | Diode Laser Tips |
44 | 00647529001622 | MX Turbo Tips | 7200406 | A tip kit containing 2 reusable laser tips intended for use with Waterlase laser A tip kit containing 2 reusable laser tips intended for use with Waterlase laser systems. The tips have the same length of 2 mm and vary in core diameter. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser Tips |
45 | 00647529001073 | RFT3-21 | A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser Tips | |
46 | 00647529001066 | RFT3-17 | A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser Tips | |
47 | 00647529001059 | RFT2-25 | A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser Tips | |
48 | 00647529001042 | RFT2-21 | A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser Tips | |
49 | 00647529001035 | RFPT8-10 | A single-use fiberoptic tip accessory intended for use with Waterlase laser deli A single-use fiberoptic tip accessory intended for use with Waterlase laser delivery systems. | GEX | Powered Laser Surgical Instrument | 2 | Waterlase Laser Tips | |
50 | 00647529000984 | MGG6-9 | A reusable fiberoptic tip accessory intended for use with Waterlase laser delive A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery systems. | GEX | Powered Laser Surgical Instrument | Waterlase Laser Tips |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03830054230996 | M002-6A/2 PRO | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | LightWalker ST-E PRO | FOTONA D.O.O. | |
2 | 03830054230897 | M002-6A/2 ADVANCED | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker ST-E ADVANCED | FOTONA D.O.O. | |
3 | 03830054230798 | M021-5AF/2 ADVANCED | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker DT ADVANCED | FOTONA D.O.O. | |
4 | 03830054230699 | M021-5AF/1 S | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic anddermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker AT S | FOTONA D.O.O. | |
5 | 03830054230590 | M002-6A/2 STAND | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker ST-E STAND | FOTONA D.O.O. | |
6 | 03830054230514 | M002-6A/2 | The device and its accessories are intended to be used in the fields of dentistr The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urology, ENT, surgery and pain management. | TimeWalker ST-E | FOTONA D.O.O. | |
7 | 03830054230507 | M021-5AF/1 | The device and its accessories are intended to be used in the fields of dentistr The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urology, ENT, surgery and pain management. | TimeWalker AT | FOTONA D.O.O. | |
8 | 03830054230491 | M021-5AF/2 STAND | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that opehttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=create#rates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery | Lightwalker DT STAND | FOTONA D.O.O. | |
9 | 03830054230484 | M031-3A/2 PQX | The Fotona StarWalker PQX laser system and its accessories are intended for tatt The Fotona StarWalker PQX laser system and its accessories are intended for tattoo removal, treatment of pigmented lesions and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and ablation and vaporization of soft tissue in general dermatology. | StarWalker | FOTONA D.O.O. | |
10 | 03830054230408 | M321-B | The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attac The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen. | SkyPulse | FOTONA D.O.O. | |
11 | 03830054230392 | M321-A | The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attac The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen. | SkyPulse | FOTONA D.O.O. | |
12 | 03830054230354 | M031-3A/2 QX | The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization ofsoft tissue in general dermatology. | StarWalker | FOTONA D.O.O. | |
13 | 03830054230347 | M002-6A/2 ADVANCED | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | LightWalker ST-E ADVANCED | FOTONA D.O.O. | |
14 | 03830054230330 | M031-3A/2 MAQX | The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization ofsoft tissue in general dermatology. | StarWalker | FOTONA D.O.O. | |
15 | 03830054230293 | M002-6A/2 | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker ST-E | FOTONA D.O.O. | |
16 | 03830054230231 | M001-14F 2 | "The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the "The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with an undercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length." | Fotona XP-2 Focus | FOTONA D.O.O. | |
17 | 03830054230224 | M001-14F 1 | The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the X The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with anundercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length. | Fotona XP Focus | FOTONA D.O.O. | |
18 | 03830054230217 | M001-12F | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery. | XP Spectro | FOTONA D.O.O. | |
19 | 03830054230200 | M021-4AF/3 | "The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in "The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, as well as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery." | SP Spectro | FOTONA D.O.O. | |
20 | 03830054230194 | M021-5AF/1 | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range.The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic anddermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker AT | FOTONA D.O.O. | |
21 | 03830054230170 | M001-14F | The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the X The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with anundercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length. | Fotona XP Focus | FOTONA D.O.O. | |
22 | 03830054230163 | M001-12F | The Fotona XP Max (DualisXP Plus II) laser system incorporates a treatment laser The Fotona XP Max (DualisXP Plus II) laser system incorporates a treatment laser that operates in the invisible near-infrared range of the electromagnetic spectrum, and an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length.The Fotona XP Max (DualisXP Plus II) laser system incorporates the following laser sources:· A long-pulse Nd:YAG laser, with a wavelength of 1064 nm· An aiming beam diode laser, with a wavelength of 650 nmThe Fotona XP MAX (DualisXP Plus II) Nd:YAG laser system and its accessories is indicated for use in surgical and aesthetic applications requiring the selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology. | Fotona XP Max | FOTONA D.O.O. | |
23 | 03830054230125 | M002-2A | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery. | XS Dynamis | FOTONA D.O.O. | |
24 | 03830054230118 | M001-12F | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery | XP Dynamis | FOTONA D.O.O. | |
25 | 03830054230101 | M021-4AF/3 | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery. | SP Dynamis | FOTONA D.O.O. | |
26 | 03830054230095 | M021-5AF/2 | "The Fotona LightWalker laser system range incorporates treatment lasers that op "The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. " | Lightwalker DT | FOTONA D.O.O. | |
27 | 03830054230064 | M031-3A/2 | The Fotona QX laser system family incorporates a treatment laser that operates i The Fotona QX laser system family incorporates a treatment laser that operates in the invisible mid-infrared and visible range of the electromagnetic spectrum.Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length.The Fotona QX MAX laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aestheticapplications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization of soft tissue in generaldermatology. | Fotona QX Max | FOTONA D.O.O. | |
28 | 03760227850198 | SK+-EO-980-25-600-3 | STERILE MEDICAL HANDPIECE FOR SINGLE USE | SMOOTHKIT+ | LSO MEDICAL | |
29 | 03760227850174 | OSYHAND | STERILE MEDICAL HANDPIECE FOR SINGLE USE | OSYHAND | LSO MEDICAL | |
30 | 03760227850150 | PH-EO-980-25-600-3 | STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE | OSYFIBRE | LSO MEDICAL | |
31 | 03700542625569 | VITRA 2 | The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is inte The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. | VITRA 2 | QUANTEL MEDICAL | |
32 | 03700542625415 | VMS | 532nm Multispot LaserRetinal Photocoagulation | VITRA MULTISPOT | QUANTEL MEDICAL | |
33 | 03700542625309 | SUPSC532OPT | SUPRASCAN 532nm adaptor for OPTIMIS II (MultiSpot) | SUPRASCAN 532nm for OPTIMIS II | QUANTEL MEDICAL | |
34 | 03700542625293 | SUPSC532 | 532nm adaptor for HS900 BM/BQ Slit Lamp (MultiSpot) | SUPRASCAN 532nm | QUANTEL MEDICAL | |
35 | 03662824000207 | D029AF001C08A | E>EYE C | E-SWIN | ||
36 | 011000009 | AL 10000 V400 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
37 | 011000008 | AL 10000 V400 XL 7 series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
38 | 011000007 | AL 10000 V7 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
39 | 011000006 | AL 10000 V700 XL | XTRAC | STRATA SKIN SCIENCES, INC. | ||
40 | 011000005 | AL 10000 V700 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
41 | 011000004 | AL 10000 V400XL | XTRAC | STRATA SKIN SCIENCES, INC. | ||
42 | 011000002 | AL10000 V400 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
43 | 010822603 | AL 8000 Ultra Plus 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
44 | 010822602 | AL 8000 Ultra Plus | XTRAC | STRATA SKIN SCIENCES, INC. | ||
45 | 010800004 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
46 | 010800003 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
47 | 010800002 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
48 | 010800001 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
49 | 00894338002962 | OTO-HP-4 | OTO-HP-4 | Handpiece | BeamPath OTO Handpiece, 4cm working length | OMNIGUIDE, INC. |
50 | 00894338002955 | 321019 | 321019 | Elevate™ENT Handpiece | Elevate™ENT Handpiece 14cm 21° -S | OMNIGUIDE, INC. |