No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 27290016541223 | PK000344 | GEX,ONF | Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrum Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | ACDUAL Light Block package | ||
2 | 07290016541717 | SPK160001 | PKT,PBX | Laser For Disruption Of Adipocyte Cells For Aesthetic Use,Massager, Vacuum, Radi Laser For Disruption Of Adipocyte Cells For Aesthetic Use,Massager, Vacuum, Radio Frequency Induced Heat | 2 | (MP)2 APPLICATOR SERVICE PACK, Bliss | ||
3 | 07290016541199 | PK000326 | GEX,ONF | Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrum Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | Venus Versa - SR580 light block package | ||
4 | 07290016541168 | PK000323 | GEX,ONF | Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrum Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | Venus Versa - HR 650XL light block package | ||
5 | 07290016541083 | PK000130 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Viva GLB package | ||
6 | 07290016540482 | AS120070 | RF applicator intended for dermatological procedures requiring ablation and resu RF applicator intended for dermatological procedures requiring ablation and resurfacing of the skin. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | Venus Viva applicator | ||
7 | 07290016540444 | AS120059 | IPL applicator indicated for the removal of unwanted hair and to effect stable l IPL applicator indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | HR690XL applicator | ||
8 | 07290016540161 | FRWMUS250025E | The Venus Freeze (MP)2 system is a non invasive device intended for use in derma The Venus Freeze (MP)2 system is a non invasive device intended for use in dermatologic and general procedures for females for the non invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin I-IV. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Freeze MP2 | |
9 | 07290016540024 | AS100006 | The Venus Legacy device is intended for the treatment of the following medical The Venus Legacy device is intended for the treatment of the following medical conditions; usingthe applicators for delivery of non-thermal RF combined with massage and magneticfield pulses:• Relief of minor muscle aches and pain, relief of muscle spasm• Temporary improvement of local blood circulation• Temporary reduction in the appearance of cellulite | PBX,GEI | Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagul Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagulation & Accessories | LB1 applicator | ||
10 | 07290016541359 | AS140060 | GEX | Powered Laser Surgical Instrument | 2 | Venus Velocity applicator full package | ||
11 | 07290016541090 | PK000131 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Viva GLB applicator spare parts package | ||
12 | 07290016541069 | AS110011GLB | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Viva GLB applicator | ||
13 | 07290016540659 | AS140017 | Medium Light Guide (13x27x57) | GEX | Powered Laser Surgical Instrument | 2 | Medium Light Guide | |
14 | 07290016540413 | AS120031 | IPL applicator indicated for the removal of unwanted hair and to effect stable l IPL applicator indicated for the removal of unwanted hair and to effect stable long-term orpermanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in thenumber of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | HR650 applicator | ||
15 | 07290016540390 | AS120033 | • Treatment of benign pigmented epidermal and cutaneous lesions including: dysch • Treatment of benign pigmented epidermal and cutaneous lesions including: dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules.• Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | SR515 applicator | |
16 | 07290016540321 | AS110011 | Venus Viva applicator is designed for use in dermatological procedures requiring Venus Viva applicator is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Viva applicator | |
17 | 07290016540260 | AS112011 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Viva applicator | ||
18 | 07290016540178 | FRWWM71 | Diamondpolar applicator is a non invasive device intended for use in dermatolog Diamondpolar applicator is a non invasive device intended for use in dermatologic and general procedures for females for the non invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin I-IV. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | Diamondpolar applicator for Venus Freeze | ||
19 | 07290016540086 | LE100004 | GEI,PBX | Electrosurgical, Cutting & Coagulation & Accessories,Massager, Vacuum, Radio Fre Electrosurgical, Cutting & Coagulation & Accessories,Massager, Vacuum, Radio Frequency Induced Heat | 2 | Venus Legacy - 110V System | ||
20 | 07290016540048 | AS100008 | The Venus Legacy device is intended for the treatment of the following medical The Venus Legacy device is intended for the treatment of the following medical conditions; usingthe applicators for delivery of non-thermal RF combined with massage and magneticfield pulses:• Relief of minor muscle aches and pain, relief of muscle spasm• Temporary improvement of local blood circulation• Temporary reduction in the appearance of cellulite | PBX,GEI | Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagul Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagulation & Accessories | LF2 applicator | ||
21 | 07290016541625 | AS160004 | PKT,PBX | Laser For Disruption Of Adipocyte Cells For Aesthetic Use,Massager, Vacuum, Radi Laser For Disruption Of Adipocyte Cells For Aesthetic Use,Massager, Vacuum, Radio Frequency Induced Heat | 2 | BODY LASER APPLICATOR BLISS | ||
22 | 07290016541052 | VI102402GLB | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Vila GLB system | ||
23 | 07290016540277 | PK000090 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Viva kit package | ||
24 | 07290016540239 | AS121010 | The Venus Freeze Plus system is a non invasive device intended for use in dermat The Venus Freeze Plus system is a non invasive device intended for use in dermatologic and general procedures for females for the non invasive treatment of moderate to severe facial wrinkle and rhytides in Fitzpatrick skin I-IV | GEI | Electrosurgical, Cutting & Coagulation & Accessories | Diamondpolar applicator for Freeze Plus | ||
25 | 07290016540185 | FRWWM61 | Octipolar applicator is a non invasive device intended for use in dermatologic Octipolar applicator is a non invasive device intended for use in dermatologic and general procedures for females for the non invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin I-IV. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | Octipoar applicator for Venus Freeze | ||
26 | 07290016540079 | PK000041 | Venus Legacy LB1 and LF1 applicators package for shipment | PBX,GEI | Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagul Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagulation & Accessories | 2 | LB1 + LF1 kit | |
27 | 07290016540031 | AS100007 | The Venus Legacy device is intended for the treatment of the following medical The Venus Legacy device is intended for the treatment of the following medical conditions; usingthe applicators for delivery of non-thermal RF combined with massage and magneticfield pulses:• Relief of minor muscle aches and pain, relief of muscle spasm• Temporary improvement of local blood circulation• Temporary reduction in the appearance of cellulite | PBX,GEI | Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagul Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagulation & Accessories | LF1 applicator | ||
28 | 07290016540000 | LE120004 | The Venus Legacy device is intended for the treatment of the following medical The Venus Legacy device is intended for the treatment of the following medical conditions; usingthe applicators for delivery of non-thermal RF combined with massage and magneticfield pulses:Relief of minor muscle aches and pain, relief of muscle spasmTemporary improvement of local blood circulationTemporary reduction in the appearance of cellulite | PBX,GEI | Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagul Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Legacy | |
29 | 07290016541618 | AS160043 | PBX,PKT | Massager, Vacuum, Radio Frequency Induced Heat,Laser For Disruption Of Adipocyte Massager, Vacuum, Radio Frequency Induced Heat,Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 2 | (MP)2 APPLICATOR BLISS | ||
30 | 07290016541182 | PK000325 | GEX,ONF | Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrum Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | Venus Versa - SR515 light block package | ||
31 | 07290016540765 | AS100063 | PBX,GEI | Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagul Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Legacy CX - LB2 applicator (new design) | ||
32 | 07290016540673 | PK000105 | Venus Velocity system, applicator and light guides (small, meduim and large) | GEX | Powered Laser Surgical Instrument | 2 | Venus Velocity kit | |
33 | 07290016540383 | VE102407 | The Venus Versa system is a multi-application device intended to be used in aest The Venus Versa system is a multi-application device intended to be used in aesthetic and cosmetic procedures. | ONF,GEI | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect,Electrosur Powered Light Based Non-Laser Surgical Instrument With Thermal Effect,Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Versa | |
34 | 07290016540468 | AS120053 | MP2 applicator intended for use in dermatologic and general surgery procedures f MP2 applicator intended for use in dermatologic and general surgery procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | Octipolar applicator | ||
35 | 07290016540314 | AS110009 | Diamondpolar applicator is designed for use in dermatological procedures requir Diamondpolar applicator is designed for use in dermatological procedures requiring treatment of moderate to severe facial wrinkles and rhytides. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | Diamond applicator | ||
36 | 07290016540307 | VI102402 | The Venus Viva system is intended for dermatological procedures requiring ablati The Venus Viva system is intended for dermatological procedures requiring ablation andresurfacing of the skin. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Viva | |
37 | 07290016540062 | PK000039 | Venus Legacy LB2 and LF2 applicators package for shipment. | PBX,GEI | Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagul Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagulation & Accessories | 2 | LB2 + LF2 kit | |
38 | 07290016541533 | LE120004NI | PBX,GEI | Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagul Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Legacy 110V - Nikao | ||
39 | 07290016541281 | BL000001 | The Venus Bliss device is a diode laser system intended for non-invasive lipolys The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomenand flanks in individuals with a Body Mass Index (BMI) of 30 or less.In addition, the Venus Bliss device is intended for the treatment of the following medicalconditions; using the MP2 applicator for delivery of RF energy combined with massage andmagnetic field pulses:• Relief of minor muscle aches and pain, relief of muscle spasm• Temporary improvement of local blood circulation• Temporary reduction in the appearance of cellulite | PKT,PBX | Laser For Disruption Of Adipocyte Cells For Aesthetic Use,Massager, Vacuum, Radi Laser For Disruption Of Adipocyte Cells For Aesthetic Use,Massager, Vacuum, Radio Frequency Induced Heat | 2 | BLISS SYSTEM | |
40 | 07290016541106 | PK000132 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Viva GLB Diamondpolar applicator spare parts package | ||
41 | 07290016540741 | AS112010 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Venus Viva - Diamondpolar applicator | ||
42 | 07290016540635 | AS140010 | Diode laser applicator | GEX | Powered Laser Surgical Instrument | Venus Velocity Applicator | ||
43 | 07290016540628 | VL000001 | The Venus Concept Velocity Diode Laser is intended for all Fitzpatrick skin type The Venus Concept Velocity Diode Laser is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for:• Hair removal;• Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and• Treatment of pseudofolliculitis barbae. | GEX | Powered Laser Surgical Instrument | 2 | Venus Velocity | |
44 | 07290016540451 | AS120058 | IPL applicator intended to be used for the treatment of acne vulgaris. | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | ACDUAL applicator | |
45 | 07290016540437 | AS120060 | IPL applicator indicated for the removal of unwanted hair and to effect stable l IPL applicator indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | HR650XL applicator | |
46 | 07290016540420 | AS120030 | IPL applicator indicated for the removal of unwanted hair and to effect stable l IPL applicator indicated for the removal of unwanted hair and to effect stable long-term orpermanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in thenumber of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | HR690 applicator | |
47 | 27290016541179 | PK000324 | GEX,ONF | Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrum Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | HR 690XL Light Block package | ||
48 | 07290016541724 | AS160027 | PKT,PBX | Laser For Disruption Of Adipocyte Cells For Aesthetic Use,Massager, Vacuum, Radi Laser For Disruption Of Adipocyte Cells For Aesthetic Use,Massager, Vacuum, Radio Frequency Induced Heat | 2 | Belt Bliss | ||
49 | 07290016540666 | AS140018 | Large Light Guide (20x35x51) | GEX | Powered Laser Surgical Instrument | 2 | Large Light Guide | |
50 | 07290016540406 | AS120032 | IPL applicator. Treatment of benign pigmented epidermal and cutaneous lesions in IPL applicator. Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides(freckles), lentigines, nevi, and cafe-au-lait macules. Treatment of benign cutaneous vascular lesions including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | SR580 applicator |
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 | 03662824000207 | D029AF001C08A | E>EYE C | E-SWIN | ||
37 | 011000009 | AL 10000 V400 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
38 | 011000008 | AL 10000 V400 XL 7 series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
39 | 011000007 | AL 10000 V7 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
40 | 011000006 | AL 10000 V700 XL | XTRAC | STRATA SKIN SCIENCES, INC. | ||
41 | 011000005 | AL 10000 V700 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
42 | 011000004 | AL 10000 V400XL | XTRAC | STRATA SKIN SCIENCES, INC. | ||
43 | 011000002 | AL10000 V400 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
44 | 010822603 | AL 8000 Ultra Plus 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
45 | 010822602 | AL 8000 Ultra Plus | XTRAC | STRATA SKIN SCIENCES, INC. | ||
46 | 010800004 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
47 | 010800003 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
48 | 010800002 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
49 | 010800001 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
50 | 00894338002962 | OTO-HP-4 | OTO-HP-4 | Handpiece | BeamPath OTO Handpiece, 4cm working length | OMNIGUIDE, INC. |