| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00852306007166 | GYN-HP-29 | GYN-HP-29 | Handpiece, GYN, Mark III, 29 cm, Straight w/ Strain Relief | GEX | Powered Laser Surgical Instrument | 2 | GYN-Laparoscopic Handpiece, 29 cm, Straight |
| 2 | 00852306007104 | NEURO-HP-6B | NEURO-HP-6B | Handpiece, NEURO, Mark III, 6cm Bayonet | GEX | Powered Laser Surgical Instrument | 2 | NEURO Handpiece, 6cm, Bent |
| 3 | 00852306007074 | GYN-TRAY-LAP-1 | GYN-TRAY-LAP-1 | Handpiece Metal Tray for GYN Laparoscopic Handpieces | GEX | Powered Laser Surgical Instrument | 2 | GYN-LAP Handpiece Tray |
| 4 | 00894338002931 | 321012 | 321012 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 22cm 45°/15° -S |
| 5 | 00894338002894 | 321008 | 321008 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 22cm 45°/0° -S |
| 6 | 00894338002726 | FELS-25A | FELS-25A | FELS Laser System | GEX | Powered Laser Surgical Instrument | 2 | FELS Laser System |
| 7 | 00852306007128 | NEURO-HP-8 | NEURO-HP-8 | Handpiece, NEURO, Mark III, 8cm, Straight | GEX | Powered Laser Surgical Instrument | 2 | NEURO Handpiece, 8cm, Straight |
| 8 | 00894338002962 | OTO-HP-4 | OTO-HP-4 | Handpiece | GEX | Powered Laser Surgical Instrument | 2 | BeamPath OTO Handpiece, 4cm working length |
| 9 | 00894338002818 | ROBOTIC | ROBOTIC | Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | BeamPath ROBOTIC fiber |
| 10 | 00894338002023 | 321002 | 321002 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 7cm 0°-S |
| 11 | 00894338002016 | FLEXGUIDE-ULTRA | FLEXGUIDE-ULTRA | BeamPath Robotic Fiber Conduit | GEX | Powered Laser Surgical Instrument | 2 | Flexguide Ultra Handpiece |
| 12 | 00852306007203 | GYN-HP-13 | GYN-HP-13 | Handpiece, GYN, Mark III, 13 cm, Straight | GEX | Powered Laser Surgical Instrument | 2 | GYN Handpiece Mark III, 13 cm |
| 13 | 00852306007265 | 321015 | 321015 | ELEVATE™ ENT Instrumentation Set of 13 Elevate ENT Handpieces and 1 tray | GEX | Powered Laser Surgical Instrument | 2 | ELEVATE™ ENT Instrumentation Set - 13 |
| 14 | 00852306007258 | GYN-HS-LGT | GYN-HS-LGT | BeamPath GYN-LGT Handpiece Set, 5 Handpieces & Tray | GEX | Powered Laser Surgical Instrument | 2 | BeamPath GYN-LGT Handpiece Set |
| 15 | 00852306007081 | NEURO-HP-3.5 | NEURO-HP-3.5 | Handpiece, NEURO, Mark III, 3.5cm, Straight | GEX | Powered Laser Surgical Instrument | 2 | NEURO Handpiece, 3.5cm, Straight |
| 16 | 00852306007036 | NEURO-TRAY | NEURO-TRAY | Handpiece Tray for Neurology | GEX | Powered Laser Surgical Instrument | 2 | NEURO Handpiece Tray |
| 17 | 00894338002924 | 321011 | 321011 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 22cm 45°/30° -S |
| 18 | 00894338002917 | 321010 | 321010 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 22cm 45°/15° |
| 19 | 00894338002672 | NEURO-L | NEURO-L | Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | BeamPath NEURO-L Fiber |
| 20 | 00852306007715 | 60 Watt | 420060-AA | A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use line of sight laser energy or fiber supplied laser energy for use with the OmniGuide waveguide laser fiber | GEX | Powered Laser Surgical Instrument | 2 | Beacon Advanced Energy CO2 Laser System |
| 21 | 00852306007289 | OTO-HS | OTO-HS | OTO Handpiece Set with 2 OTO Handpieces and OTO Tray | GEX | Powered Laser Surgical Instrument | 2 | BeamPath OTO Handpiece Set |
| 22 | 00852306007210 | GYN-HP-13B | GYN-HP-13B | Handpiece, GYN, Mark III, 13 cm, Single Bend | GEX | Powered Laser Surgical Instrument | 2 | GYN Handpiece Mark III, 13 cm Bent |
| 23 | 00852306007043 | 341005 | 341005 | Handpiece Tray for Gynecology | GEX | Powered Laser Surgical Instrument | 2 | Core GYN Tray |
| 24 | 00894338002863 | 341001 | 341001 | Lapflex Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Lapflex, Laparoscopic Articulating Handpiece- 33cm |
| 25 | 00894338002351 | OTO-TRAY | OTO-TRAY | Handpiece Tray for Otology | GEX | Powered Laser Surgical Instrument | 2 | Handpiece Tray for AccuBeam Otology |
| 26 | 00894338002030 | 321003 | 321003 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 7cm 25°-S |
| 27 | 00852306007296 | 321016 | 321016 | ELEVATE™ ENT Instrumentation Set of 11 Elevate ENT Handpieces and 1 tray | GEX | Powered Laser Surgical Instrument | 2 | ELEVATE™ ENT Instrumentation Set - 11 |
| 28 | 00852306007159 | GYN-LAP-33B | GYN-LAP-33B | Handpiece, Fixed Bend, Laparoscopic, 33 cm X 5 mm | GEX | Powered Laser Surgical Instrument | 2 | GYN-LAP Handpiece, 33cm, Bent |
| 29 | 00852306007098 | NEURO-HP-5 | NEURO-HP-5 | Handpiece, NEURO, Mark III, 5cm, Straight | GEX | Powered Laser Surgical Instrument | 2 | NEURO Handpiece, 5cm, Straight |
| 30 | 00852306007029 | FLEX-TRAY | FLEX-TRAY | Robotic Flexible Handpiece Tray, MediTray Aluminum Wide Mid Size Slim Case, 9.8" Robotic Flexible Handpiece Tray, MediTray Aluminum Wide Mid Size Slim Case, 9.8" x 8.1" x 0.8" | GEX | Powered Laser Surgical Instrument | 2 | FLEXGUIDE-ULTRA Handpiece Tray |
| 31 | 00852306007012 | 341002 | 341002 | LapFlex Instrumentation Tray to use with the Lapflex Handpiece. | GEX | Powered Laser Surgical Instrument | 2 | OmniGuide® LapFlex Tray |
| 32 | 00852306007005 | 321014 | 321014 | Elevate™ ENT Instrumentation Tray (13 Slot) to use with the elevate ENT handpieces | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ ENT Instrumentation Tray |
| 33 | 10894338002693 | ACC-GFU-100 | ACC-GFU-100 | Gas Filter Unit, Box of 10 | GEX | Powered Laser Surgical Instrument | Gas Filter Unit | |
| 34 | 00894338002948 | 321018 | 321018 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 5cm 25° -S |
| 35 | 00894338002047 | OTO-S | OTO-S | Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | BeamPath OTO-S fiber |
| 36 | 00852306007708 | 1 | 323000 | The OmniGuide TRIO multi-functional handpiece combines three fundamental surgica The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact handheld disposable surgical instrument. It enables a surgeon to provide fluid suction, bipolar cautery and CO2 laser energy delivered via a flexible OmniGuide fiber for minimally invasive surgery. The handpiece is delivered sterile, and is intended for one-time use only. TRIO has been validated to be used with the Valleylab Triad or Valleylab Force FX. | GEI,GEX | Electrosurgical, Cutting & Coagulation & Accessories,Powered Laser Surgical Instrument | 2 | TRIO Handpiece |
| 37 | 00852306007067 | GYN-TRAY-LGT | GYN-TRAY-LGT | Handpiece Tray for GYN Lower Genital Handpiece Set (GYN-HS-LGT) | GEX | Powered Laser Surgical Instrument | 2 | GYN-LGT Handpiece Tray |
| 38 | 00894338002955 | 321019 | 321019 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 14cm 21° -S |
| 39 | 00894338002900 | 321009 | 321009 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 22cm 45°/30° |
| 40 | 00894338002054 | OTO-M | OTO-M | Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | BeamPath OTO-M fiber |
| 41 | 00852306007319 | GYN-HS-MIS | GYN-HS-MIS | GYN MIS Robotic & Laparoscopic Instrumentation Set, 3 Handpieces & Tray | GEX | Powered Laser Surgical Instrument | 2 | GYN MIS Robotic & Laparoscopic Instrumentation Set |
| 42 | 00852306007272 | NEURO-HS | NEURO-HS | NEURO Handpiece Set, 6 Neuro Handpieces and Neuro Tray | GEX | Powered Laser Surgical Instrument | 2 | BeamPath NEURO Handpiece Set |
| 43 | 00852306007180 | GYN-HP-3.5 | GYN-HP-3.5 | Handpiece, GYN, Mark III, 3.5 cm, Straight | GEX | Powered Laser Surgical Instrument | 2 | GYN Handpiece, 3.5 cm, Straight |
| 44 | 00894338002887 | 321007 | 321007 | Elevate™ENT Handpiece | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ENT Handpiece 17cm 45°/15° |
| 45 | 00894338002825 | 322001 | 322001 | Laser Fiber | GEX | Powered Laser Surgical Instrument | 2 | Elevate™ ENT Elite Fiber |
| 46 | 00852306007302 | FLEX-ULTRA SET | FLEX-ULTRA SET | FlexGuide ULTRA set with Fleguide Handpiece and Tray | GEX | Powered Laser Surgical Instrument | 2 | FlexGuide ULTRA with Tray |
| 47 | 00852306007241 | GYN-HS-LAP-1 | GYN-HS-LAP-1 | GYN Laparoscopic Handpiece Set, 2 Handpieces(GYN-LAP-33B and GYN-HP-46) & Tray(H GYN Laparoscopic Handpiece Set, 2 Handpieces(GYN-LAP-33B and GYN-HP-46) & Tray(Handpiece Tray, GYN, LAP) | GEX | Powered Laser Surgical Instrument | 2 | BeamPath GYN-LAP Handpiece Set |
| 48 | 00852306007234 | 341004 | 341004 | OmniFlex Instrumentation Set, LapFlex (1 Piece), FlexGuide Ultra (1 Piece) and Tray | GEX | Powered Laser Surgical Instrument | 2 | OmniGuide® OmniFlex Instrument Set |
| 49 | 00852306007227 | 341003 | 341003 | LapFlex Instrumentation Set (1 HandPiece & 1 Tray) | GEX | Powered Laser Surgical Instrument | 2 | OmniGuide® LapFlex Instrument Set |
| 50 | 00852306007197 | GYN-HP-6B | GYN-HP-6B | Handpiece, GYN, Mark III, 6 cm, Single Bend | GEX | Powered Laser Surgical Instrument | 2 | GYN Handpiece Mark III, 6 cm Bent |
| 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. |