| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 07290109145037 | O.R. | GEX | Powered Laser Surgical Instrument | 2 | UltraPulse α | ||
| 2 | 07290109147260 | Lumenis Pulse 100H | GA-1008944D | GEX | Powered Laser Surgical Instrument | 2 | Lumenis Pulse 100H | |
| 3 | 07290109143453 | Moses™ 550 D\F\L | GEX | Powered Laser Surgical Instrument | 2 | Moses™ 550 D\F\L | ||
| 4 | 07290118853237 | Digital AcuBlade Upgrade Kit | KTCE03300 | This kit includes DI 07290109142456 in it | GEX | Powered Laser Surgical Instrument | 2 | Digital AcuBlade Upgrade Kit |
| 5 | 07290109147062 | VersaPulse PowerSuite 80/100W | 0638-800-01D | GEX | Powered Laser Surgical Instrument | 2 | VersaPulse PowerSuite 80/100W | |
| 6 | 07290109147055 | VersaPulse PowerSuite 80/100W | 0638-800-00D | GEX | Powered Laser Surgical Instrument | 2 | VersaPulse PowerSuite 80/100W | |
| 7 | 07290109147024 | 19119 | AA0590500 | GEX | Powered Laser Surgical Instrument | 2 | MicroSlad™ 719 Lens Slide 275 mm | |
| 8 | 07290109146850 | VersaCut™ | 0636-470-01 | VersaCut Tissue Morcellator Control Unit | GCJ | Laparoscope, General & Plastic Surgery | 2 | VersaCut™ |
| 9 | 07290109146225 | VersaPulse Powersuite 80/100W | 0638-807-01 | GEX | Powered Laser Surgical Instrument | 2 | VersaPulse Powersuite | |
| 10 | 07290109145600 | SlimLine™ SIS 550 | 0644-021-01 | GEX | Powered Laser Surgical Instrument | 2 | SlimLine™ SIS 550 | |
| 11 | 07290109145273 | OptiLight IPL Upgrade Kit | QIU,GEX,ONF,ONG | Intense Pulsed Light Device For Managing Dry Eye,Powered Laser Surgical Instrume Intense Pulsed Light Device For Managing Dry Eye,Powered Laser Surgical Instrument,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect,Powered Laser Surgical Instrument With Microbeam\Fractional Output | 2 | OptiLight IPL Upgrade Kit | ||
| 12 | 07290109144948 | Stellar SapphireCool LG 8x15 | ONG,ONF,GEX | Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Light Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect,Powered Laser Surgical Instrument | 2 | Stellar SapphireCool LG 8x15 | ||
| 13 | 07290109144917 | Rosacea IV-V Filter | QIU | Intense Pulsed Light Device For Managing Dry Eye | 2 | Rosacea IV-V Filter | ||
| 14 | 07290109144849 | Stellar M22 695 nm filter | ONF,ONG,GEX | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect,Powered La Powered Light Based Non-Laser Surgical Instrument With Thermal Effect,Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Laser Surgical Instrument | 2 | Stellar M22 695 nm filter | ||
| 15 | 07290109144672 | Lumenis Pulse 60H, 60Hz | GEX | Powered Laser Surgical Instrument | 2 | Lumenis Pulse 60H, 60Hz | ||
| 16 | 07290109144641 | Stellar Optima™ | GEX,ONF,ONG,QIU | 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,Powered Laser Surgical Instrument With Microbeam\Fractional Output,Intense Pulsed Light Device For Managing Dry Eye | 2 | Stellar Optima™ | ||
| 17 | 07290109143439 | Universal IPL 695 nm Expert Filter (Set 4) | ONF,ONG,GEX | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect,Powered La Powered Light Based Non-Laser Surgical Instrument With Thermal Effect,Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Laser Surgical Instrument | 2 | Universal IPL 695 nm Expert Filter | ||
| 18 | 07290109143125 | LightSheer Desire HS 1060 Handpiece | GEX | Powered Laser Surgical Instrument | 2 | LightSheer Desire HS 1060 Handpiece | ||
| 19 | 07290109143071 | FemTouch™ Standard Focus Disposable Tips Pack | GEX | Powered Laser Surgical Instrument | FemTouch™ Standard Focus Disposable Tips | |||
| 20 | 07290109143026 | M22 ResurFX Handpiece | GEX,ONG,ONF | Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbe Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | M22 ResurFX Handpiece | ||
| 21 | 07290109142937 | AcuPulse™ Upgrade Kit to AES-A 4 Modes Upgrade | GEX | Powered Laser Surgical Instrument | 2 | AcuPulse™ Upgrade Kit to AES-A 4 Modes Upgrade | ||
| 22 | 07290109142890 | AcuPulse™ Upgrade Kit 40 to 40AES-R | Additional DM UDI:07290109144054;07290109144061;07290109144047;07290109144078 | GEX | Powered Laser Surgical Instrument | AcuPulse™ Upgrade Kit 40 to 40AES-R | ||
| 23 | 07290109142852 | AcuPulse™ Upgrade Kit 40AES-R To 40AES-A | GEX | Powered Laser Surgical Instrument | 2 | AcuPulse™ Upgrade Kit 40AES-R To 40AES-A | ||
| 24 | 07290109142845 | AcuPulse™ Upgrade Kit 40AES-F to 40AES-R | Additional DM UDI:07290109144054;07290109144047;07290109144078;07290109144122 | GEX | Powered Laser Surgical Instrument | AcuPulse™ Upgrade Kit 40AES-F to 40AES-R | ||
| 25 | 07290109142760 | Xplume 9615 Smoke Evacuation Autoclavable Plastic Funnel Set | GEX | Powered Laser Surgical Instrument | 2 | Xplume 9615 Smoke Evacuation Autoclavable Plastic Funnel Set | ||
| 26 | 07290109142562 | Q-Switch Nd:YAG Disposable Tips Spot Size 5 mm | GEX,ONF,ONG | 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,Powered Laser Surgical Instrument With Microbeam\Fractional Output | 2 | Q-Switch Nd:YAG Disposable Tips Spot Size 5 mm | ||
| 27 | 07290109142517 | SS FiberLase™ Accessory Starter Kit with FiberLase Fiber | GEX | Powered Laser Surgical Instrument | 2 | SS FiberLase™ Accessory Starter Kit with FiberLase Fiber | ||
| 28 | 07290109142494 | VersaCut+ Blade Set | GCJ | Laparoscope, General & Plastic Surgery | 2 | VersaCut+ Blade Set | ||
| 29 | 07290109142470 | FiberLase™ Accessory Starter Kit with FiberLase Fiber | GEX | Powered Laser Surgical Instrument | 2 | FiberLase™ Accessory Starter Kit with FiberLase Fiber | ||
| 30 | 07290109142401 | Upgrade kit for AcuPulse 30/40 ST | GEX | Powered Laser Surgical Instrument | 2 | SurgiTouch™ Scanner | ||
| 31 | 07290109142326 | DeepFX™ Microscanner | GEX | Powered Laser Surgical Instrument | 2 | DeepFX™ Microscanner | ||
| 32 | 07290109142272 | Q-Switch Nd:YAG Metal Treatment Tip 5 mm | GEX,ONG,ONF | Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbe Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | Q-Switch Nd:YAG Metal Treatment Tip 5 mm | ||
| 33 | 07290109142241 | AcuScan™ 120 Microscanner Upgrade Kit | GEX | Powered Laser Surgical Instrument | 2 | AcuScan™ 120 Microscanner Upgrade Kit | ||
| 34 | 07290109142203 | kit for AcuPulse and AcuPulse DUO | GEX | Powered Laser Surgical Instrument | 2 | SurgiTouch™ Scanner | ||
| 35 | 07290109142135 | Kit for UltraPulse SurgiTouch | GEX | Powered Laser Surgical Instrument | 2 | SurgiTouch™ Scanner | ||
| 36 | 07290109142111 | kit for UltraPulse/UltraPulse DUO | GEX | Powered Laser Surgical Instrument | 2 | SurgiTouch™ Scanner | ||
| 37 | 07290109141978 | Holep Kit with SIS fiber for Versacut | GCJ | Laparoscope, General & Plastic Surgery | 2 | Holep Kit with SIS fiber for Versacut | ||
| 38 | 07290109141916 | AcuSpot 712 L Micromanipulator | Additional DM DIs:0729010914429007290109144313 | GEX | Powered Laser Surgical Instrument | AcuSpot 712 L Micromanipulator | ||
| 39 | 07290109141770 | 19119 | GEX | Powered Laser Surgical Instrument | 2 | MicroSlad™ 719 Lens Slide 275 mm | ||
| 40 | 07290109141749 | 19106 | GEX | Powered Laser Surgical Instrument | 2 | MicroSlad™ 717/718 Lens Slide 200 mm | ||
| 41 | 07290109141732 | 19109 | GEX | Powered Laser Surgical Instrument | 2 | MicroSlad™ 717/718 Lens Slide 350 mm | ||
| 42 | 07290109141633 | Nezhat Coupler and Adaptors | GEX | Powered Laser Surgical Instrument | 2 | Nezhat™ Optical Coupler for Single Puncture Laparoscopes (F300 mm) | ||
| 43 | 07290109141626 | Nezhat™ Optical Coupler for Single Puncture Laparoscopes (F300 mm) | GEX | Powered Laser Surgical Instrument | 2 | Nezhat™ Optical Coupler for Single Puncture Laparoscopes (F300 mm) | ||
| 44 | 07290109141398 | 14639 | GEX | Powered Laser Surgical Instrument | Nasal Probe Bent Tip | |||
| 45 | 07290109141350 | 14633 | GEX | Powered Laser Surgical Instrument | 2 | Nasal Probe Straight Tip 90 Degree Left Mirror | ||
| 46 | 07290109141251 | SS FiberLase™ HP-R 240 mm bent, straight tip | GEX | Powered Laser Surgical Instrument | SS FiberLase™ HP-R 240 mm bent, straight tip | |||
| 47 | 07290109141220 | SS FiberLase™ HP-R 180 mm straight, curved tip | GEX | Powered Laser Surgical Instrument | SS FiberLase™ HP-R 180 mm straight, curved tip | |||
| 48 | 07290109141176 | SS FiberLase™ Handpiece Rigid Kit | GEX | Powered Laser Surgical Instrument | SS FiberLase™ Handpiece Rigid Kit | |||
| 49 | 07290109140995 | SapphireCool Light Guide 6 mm | GEX,ONG,ONF | Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbe Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | SapphireCool Light Guide 6 mm | ||
| 50 | 07290109140971 | SapphireCool Light Guide 6 mm | GEX,ONG,ONF | Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbe Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | SapphireCool Light Guide 6 mm |
| 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. |