No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00810116020591 | BHAL2120 | 48012517 | Helical Basket, 2.5 Fr diameter, 120 cm length. | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
2 | 00810116020584 | BEZ18120 | 48012516 | Tipless Basket, 1.8 Fr diameter, 120 cm length. | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
3 | 00810116020577 | BEZ15120 | 48012515 | Tipless Basket, 1.5 Fr diameter, 120 cm length. | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
4 | 00810116020560 | MERI3815S | 48012513 | Combi Nitinol Guidewire, 0.038" diameter, 150 cm length, 3 cm tip. | EYA | Stylet, Ureteral | 1 | Dornier MedTech |
5 | 00810116020485 | Slim 270 Micron Reusable | HOL200R | Dornier SmartFlex 200 Reusable Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
6 | 00810116020478 | 1000 Micron Reusable | HOL1000R | Dornier SmartFlex 1000 Reusable Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
7 | 00810116020461 | 600 Micron Reusable | HOL600R | Dornier SmartFlex 600 Reusable Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | Dornier MedTech | |
8 | 00810116020454 | 400 Micron Reusable | HOL400R | Dornier SmartFlex 400 Reusable Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
9 | 00810116020447 | 270 Micron Reusable | HOL270R | Dornier SmartFlex 270 Reusable Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
10 | 00810116020386 | 1000 Micron Single Use | HOL1000S | Dornier SingleFlex 1000 Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
11 | 00810116020379 | 600 Micron Single Use | HOL600S | Dornier SingleFlex 600 Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
12 | 00810116020362 | 400 Micron Single Use | HOL400S | Dornier SingleFlex 400 Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
13 | 00810116020355 | 270 Micron Single Use | HOL270S | Dornier SingleFlex 270 Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
14 | 00810116020331 | Slim 270 Micron Ball Tip Single Use | HOL200SBT | Dornier GentleFlex 200 Laser Fiber - Dornier Direct | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
15 | 00810116020256 | 200 Series Flex Single Use | HLFDF200C | RFID Single Use 200 Series Flex (270 Micron) Ball Tip Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
16 | 00810116020249 | 200 Series Reusable | HLFRS200C | RFID Reusable 200 Series (270 Micron) Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
17 | 00810116020218 | 200 Series Single Use | HLFDS200C | RFID Single Use 200 Series (270 Micron) Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
18 | 00810116020072 | 270 Micron Reusable | HLFR0270C | RFID Reusable 270 Micron Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
19 | 00810116020065 | 400 Micron Reusable | HLFR0400C | RFID Reusable 400 Micron Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
20 | 00810116020058 | 600 Micron Reusable | HLFR0600C | RFID Reusable 600 Micron Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
21 | 00810116020041 | 1000 Micron Reusable | HLFR1000C | RFID Reusable 1000 Micron Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
22 | 00810116020034 | 1000 Micron Single Use | HLFD1000C | RFID Single Use 1000 Micron Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
23 | 00810116020027 | 600 Micron Single Use | HLFD0600C | RFID Single Use 600 Micron Laser Fiber | GEX | Powered Laser Surgical Instrument | Dornier MedTech | |
24 | 00810116020010 | 400 Micron Single Use | HLFD0400C | RFID Single Use 400 Micron Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
25 | 00810116020003 | 270 Micron Single Use | HLFD0270C | RFID Single Use 270 Micron Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
26 | 00810116023035 | Dornier Genesis Urology Drain Bag | 10501000 | Non- sterile flexible disposable drain bag with hose adapters for use on Dornier Non- sterile flexible disposable drain bag with hose adapters for use on Dornier Genesis Urological Table | KKX | Drape, Surgical | 2 | Dornier MedTech |
27 | 00810116023028 | Equipment Cover (Movement Footswitch) | FTSXCVRLG | Nonsterile Equipment Large Cover for the Movement Footswitch 26” x 26” | IZI | System, X-Ray, Angiographic | 2 | Dornier MedTech |
28 | 00810116021291 | Cascade Ureteral Stent, 7Fr x 26cm | CAS7026 | Cascade Ureteral Stent, 7Fr x 26cm | FAD | Stent, Ureteral | 2 | Dornier MedTech |
29 | 00810116023011 | Equipment Cover (X-Ray Footswitch) | FTSXCVRSM | Nonsterile Equipment Small Cover for the X-Ray Footswitch 24” x 24” | IZI | System, X-Ray, Angiographic | 2 | Dornier MedTech |
30 | 00810116023004 | Axis Ureteroscope Reverse Deflection | AX93US31BR | Disposable Flexible Ureterscope Reverse Deflection | FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 | Dornier MedTech |
31 | 00810116022915 | 2.0Fr x 120cm, 8mm Open Tip | BVEN2128 | Nitonol Stone Extractor, 2.0Fr x 120cm, 8mm Open Tip | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
32 | 00810116022908 | 1.5Fr x 120cm,11mm Open Tip | BVEN11211 | Nitonol Stone Extractor, 1.5Fr x 120cm,11mm Open Tip | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
33 | 00810116022588 | 600 micron single use SMA | K2311580 | 600 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
34 | 00810116022564 | 400 micron single use SMA | K2311577 | 400 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters | GEX | Powered Laser Surgical Instrument | Dornier MedTech | |
35 | 00810116022540 | 600 micron single use luer lock | K2311824 | 600 micron core/1040 micron OD Luer Lock Diode Laser Fiber, 2.5 meters | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
36 | 00810116022526 | 400 micron single use luer lock | K2311822 | 400 micron core/730 micron OD Luer Lock Diode Laser Fiber, 2.5 meters | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
37 | 00810116022441 | 600 micron slim single use luer lock | K2312393 | 600 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters | GEX | Powered Laser Surgical Instrument | Dornier MedTech | |
38 | 00810116022427 | 400 micron single use luer lock | K2310710 | 400 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
39 | 00810116022403 | 365 micron single use luer lock | K2310292 | 365 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
40 | 00810116022380 | 600 micron single use luer lock | K2308084 | 600 micron core/1040 micron OD Luer Lock Diode Laser Fiber, 3.5 meters | GEX | Powered Laser Surgical Instrument | 2 | Dornier MedTech |
41 | 00810116022373 | 3 Wire Stone Grasper 2.0Fr, 120cm, 3 wire | BCLU2120 | Dornier Clutch 2.0Fr, 120cm Tipless 3 Wire Stone Retrieval Basket | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
42 | 00810116022366 | 2.0Fr x 120cm, 11mm Open Tip | BVEN21211 | Nitonol Stone Extractor, 2.0Fr x 120cm, 11mm Open Tip | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
43 | 00810116022359 | 1.5Fr x 120cm, 8mm Open Tip | BVEN1128 | Nitonol Stone Extractor, 1.5Fr x 120cm, 8mm Open Tip | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
44 | 00810116022342 | 2.5Fr x 120cm, Short Tip 4 Wire Basket | BTET2120 | Straight Stone Retrieval Basket, 2.5Fr x 120cm, Short Tip 4 Wire Basket | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
45 | 00810116022335 | 2.5Fr x 120cm, Short Tip 4 Wire Basket | BHAL2120 | Helical Stone Retrieval Basket 2.5Fr x 120cm, Short Tip 4 Wire Basket | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
46 | 00810116022328 | 2.2Fr x 120cm, Tipless Basket | BEZ22120 | Nitinol Stone Retrieval Basket 2.2Fr, 120cm, Tipless | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
47 | 00810116022311 | 1.8Fr x 120cm, Tipless Basket | BEZ18120 | Nitinol Stone Retrieval Basket 1.8Fr, 120cm, Tipless | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
48 | 00810116022304 | 1.5Fr x 120cm, Tipless Basket | BEZ15120 | Nitinol Stone Retrieval Basket 1.5Fr, 120cm, Tipless | FGO | Dislodger, Stone, Flexible | 2 | Dornier MedTech |
49 | 00810116022281 | Angle, Flexible Tip, Stiff | SLIP2515AS | Nitinol Hydrophilic Guide Wire 0.025", 150cm, Angled, 3cm tip, flexible one end, Stiff | EYA | Stylet, Ureteral | 1 | Dornier MedTech |
50 | 00810116022267 | Straight, Flexible Tip, Stiff | SLIP2515SS | Nitinol Hydrophilic Guide Wire 0.025", 150cm, Straight, 3cm tip, flexible one end, Stiff | EYA | Stylet, Ureteral | 1 | Dornier MedTech |
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. |