Other products from "FOTONA D.O.O."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 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." GEX,PDZ Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 2 Fotona XP-2 Focus
2 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." GEX,ONG Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbe Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbeam\Fractional Output 2 SP Spectro
3 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. GEX,ONG Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbe Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbeam\Fractional Output 2 SP Dynamis
4 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. " GEX,PDZ,NVK,ILY Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Laser, Dental, Soft Tissue,Lamp, Infrared, Therapeutic Heating 2 Lightwalker DT
5 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. GEX,PDZ,NVK,ILY Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Laser, Dental, Soft Tissue,Lamp, Infrared, Therapeutic Heating 2 Lightwalker ST-E
6 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. GEX,PDZ Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 2 Fotona XP Focus
7 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. PDZ,GEX,NVK,ILY Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Power Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Powered Laser Surgical Instrument,Laser, Dental, Soft Tissue,Lamp, Infrared, Therapeutic Heating 2 Lightwalker AT
8 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. GEX,PDZ Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 2 Fotona XP Focus
9 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. GEX,PDZ,NVK,ILY Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Laser, Dental, Soft Tissue,Lamp, Infrared, Therapeutic Heating 2 Lightwalker ST-E ADVANCED
10 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. GEX,PDZ,NVK,ILY Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Laser, Dental, Soft Tissue,Lamp, Infrared, Therapeutic Heating 2 Lightwalker ST-E STAND
11 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. GEX Powered Laser Surgical Instrument 2 SkyPulse
12 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. GEX Powered Laser Surgical Instrument 2 SkyPulse
13 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. GEX Powered Laser Surgical Instrument 2 XP Spectro
14 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 GEX,PDZ,NVK,ILY Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Laser, Dental, Soft Tissue,Lamp, Infrared, Therapeutic Heating 2 Lightwalker DT STAND
15 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 GEX Powered Laser Surgical Instrument 2 XP Dynamis
16 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. GEX Powered Laser Surgical Instrument 2 StarWalker
17 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. GEX Powered Laser Surgical Instrument 2 StarWalker
18 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. GEX Powered Laser Surgical Instrument 2 StarWalker
19 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. GEX Powered Laser Surgical Instrument 2 Fotona XP Max
20 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. GEX Powered Laser Surgical Instrument 2 Fotona QX Max
21 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. GEX,PDZ,NVK,ILY Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Laser, Dental, Soft Tissue,Lamp, Infrared, Therapeutic Heating 2 LightWalker ST-E PRO
22 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. GEX Powered Laser Surgical Instrument 2 TimeWalker ST-E
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. GEX,ONG Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbe Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbeam\Fractional Output 2 XS Dynamis
24 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. GEX,PDZ,NVK,ILY Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Laser, Dental, Soft Tissue,Lamp, Infrared, Therapeutic Heating 2 Lightwalker AT S
25 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. GEX,PDZ,NVK,ILY Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Powered Laser Surgical Instrument,Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis,Laser, Dental, Soft Tissue,Lamp, Infrared, Therapeutic Heating 2 Lightwalker DT ADVANCED
26 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. GEX Powered Laser Surgical Instrument 2 TimeWalker AT
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