| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | EOBN230052N0 | Laser Surgery Fiber - Dental Bare Fiber 320µm | GEX | Powered Laser Surgical Instrument | 2 | NA | ||
| 2 | EOBN270117S0 | Laser Surgery Fiber - Radial Emission Fiber 400µm Stopper | Radial Emission Fiber with Stopper, core 400µm, clad 420µm, fiber OD 900µm, whit Radial Emission Fiber with Stopper, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Jacket, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, stopper 466mm from distal end, distal conical tip with silica capillary dome 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 3 | EOBN270082S0 | Corona 360 Radial Fiber 600µm | Corona 360 Radial Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel J Corona 360 Radial Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket with length marking, customized connector, white bend protection, distal conical tip with silica capillary dome, capillary OD 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 4 | EOBN270123S0 | Laser Surgery Fiber - Radial Emission Fiber 600µm | Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jac Radial Emission Fiber, core 550µm, clad 578µm, fiber OD 1300µm, white Tefzel Jacket with length marking, SMA 905 connector, black protection cap, black bend protection, distal conical tip with silica capillary dome 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 5 | EOBN270118S0 | Laser Surgery Fiber - Radial Emission Fiber 400µm Vein | Radial Emission Fiber Vein, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Radial Emission Fiber Vein, core 400µm, clad 420µm, fiber OD 900µm, white Tefzel Jacket with length marking, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, distal conical tip with silica capillary dome 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 6 | EOBN210167S0 | Laser Surgery Fiber 600µm | Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, SMA 905 holmium connector with knurl nut, black protection cap, engraved extension sleeve red, black bend protection, distal flat tip, cleaved, 3mm stripped, NA 0.22, length 3m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 7 | EOBN270120S0 | Laser Surgery Fiber - Radial Emission Fiber 600µm Vein | Radial Emission Fiber Vein, core 550µm, clad 578µm, fiber OD 1400µm, white Tefze Radial Emission Fiber Vein, core 550µm, clad 578µm, fiber OD 1400µm, white Tefzel Jacket with length marking, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, distal conical tip with silica capillary dome 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 8 | EOBN270119S0 | Laser Surgery Fiber - Radial Emission Fiber 600µm Stopper | Radial Emission Fiber with Stopper, core 550µm, clad 578µm, fiber OD 1400µm, whi Radial Emission Fiber with Stopper, core 550µm, clad 578µm, fiber OD 1400µm, white Tefzel Jacket, SMA 905 connector, PVC protection cap, RFID extension sleeve red, black bend protection, stopper 466mm from distal end, distal conical tip with silica capillary dome 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 9 | EOBN270055S0 | Radial Emission Fiber 400µm | Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Ja Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jacket with length marking, standard SMA905 connector with knurl nut, PVC protection cap, extension sleeve red engraved, black bend protection, LUER adapter, distal conical tip with silica capillary dome, capillary OD 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 10 | EOBN270029S0 | Corona 360 Fiber 600µm | Corona 360 Fiber, core 550µm, clad 578µm, fiber OD 1400µm, white Vestodur Jacket Corona 360 Fiber, core 550µm, clad 578µm, fiber OD 1400µm, white Vestodur Jacket with length marking, customized connector, white bend protection, distal conical tip with silica capillary dome, capillary OD 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 11 | EOBN230053S0 | Laser Surgery Fiber - Chirurgie Bare Fiber 320µm | GEX | Powered Laser Surgical Instrument | 2 | NA | ||
| 12 | EOBN230051N0 | Laser Surgery Fiber - Dental Bare Fiber 200µm | GEX | Powered Laser Surgical Instrument | 2 | NA | ||
| 13 | EOBN230031S0 | Dental Surgery Fiber 320µm | Laser Surgery Fiber, core 320µm, clad 385µm, fiber OD 415µm, polyimide coating, Laser Surgery Fiber, core 320µm, clad 385µm, fiber OD 415µm, polyimide coating, standard SMA 905 connector with knurl nut, PVC protection cap, extension sleeve red engraved, black bend protection, Silicone tubing OD 2mm, distal flat tip, cleaved, 10cm freestanding fiber, NA 0.22, length 3m +/-0,2m, sterile EO, disposable, single packed, | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 14 | EOBN220126S0 | Laser Surgery Fiber 600µm | Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, Laser Surgery Fiber, core 600µm, clad 660µm, fiber OD 870µm, blue Tefzel Jacket, SMA 905 holmium connector with knurl nut, PEEK protection cap, engraved extension sleeve red, black bend protection, distal flat tip, cleaved, 3mm stripped, NA 0.22, length 3m +/-0,2m, sterile EO, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 15 | EOBN220051S0 | General Surgery Fiber 400um | Laser Surgery Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jack Laser Surgery Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jacket with length marking, standard SMA 905 connector with knurl nut, PEEK protection cap, engraved extension sleeve red, black bend protection, distal flat tip, cleaved, NA 0.22, length 3m +/-0,2m, sterile EO, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 16 | EOBN200029S0 | Laser Surgery Fiber 600µm 2.6m | Laser Surgery Fiber, core 600µm, fiber OD 950µm, transparent Tefzel Jacket, cust Laser Surgery Fiber, core 600µm, fiber OD 950µm, transparent Tefzel Jacket, customized connector, white bend protection (heat shrink tube), LUER adapter, distal flat tip, cleaved, NA 0.37, length 2,6m +/-0,2m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 17 | EOBN210138S0 | Fiber Optic for MRI blue | Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, freestanding SMA 905, black protection cap, extension sleeve silver, black PVC protection tube OD 1,5mm over 3m+/-0,1m on the proximal side, fiber stop blue 235mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 10m +/-0,05m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 18 | EOBN210137S0 | Fiber Optic for MRI green | Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, freestanding SMA 905, black protection cap, extension sleeve silver, black PVC protection tube OD 1,5mm over 3m+/-0,1m on the proximal side, fiber stop green 235mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 10m +/-0,05m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 19 | EOBN210136S0 | Fiber Optic for MRI yellow | Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, black protection cap, extension sleeve silver, black PVC protection tube OD 1,5mm over 3m+/-0,1m on the proximal side, fiber stop yellow 235mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 10m +/-0,05m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 20 | EOBN210135S0 | Fiber Optic for MRI red | Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420 Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, black protection cap, extension sleeve silver, black PVC protection tube OD 1,5mm over 3m+/-0,1m on the proximal side, fiber stop red 235mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 10m +/-0,05m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 21 | EOBN210117S0 | Fiber Optic for PLA Long blue | Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop blue 239mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 22 | EOBN210116S0 | Fiber Optic for PLA Long green | Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop green 239mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 23 | EOBN210115S0 | Fiber Optic for PLA Long yellow | Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop yellow 239mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 24 | EOBN210114S0 | Fiber Optic for PLA Long red | Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop red 239mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 25 | EOBN210113S0 | Fiber Optic for PLA Short blue | Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop blue 144mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 26 | EOBN210112S0 | Fiber Optic for PLA Short green | Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop green 144mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 27 | EOBN210111S0 | Fiber Optic for PLA Short yellow | Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop yellow 144mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA | |
| 28 | EOBN210110S0 | Fiber Optic for PLA Short red | Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 42 Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop red 144mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed | GEX | Powered Laser Surgical Instrument | 2 | NA |
| 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. |