Other products from "CLINICAL LASERTHERMIA SYSTEMS AB"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 17340007000598 4013-12 GEX Powered Laser Surgical Instrument MR Catheter
2 17340007000482 4013-06 GAH Stylet, Surgical, General & Plastic Surgery MR Stylet
3 17340007000581 4013-11 GEX Powered Laser Surgical Instrument MR Stylet
4 17340007000604 4013-13 GEX Powered Laser Surgical Instrument MR Stylet
5 17340007000574 4013-10 GEX Powered Laser Surgical Instrument MR Catheter
6 17340007000567 4013-08 GEX Powered Laser Surgical Instrument MR Stylet
7 17340007000499 4012-05 GEX Powered Laser Surgical Instrument 2 Laser Applicator Non-cooled
8 17340007000390 L-2016-051EN GEX Powered Laser Surgical Instrument 2 Thermal Therapy System Instructions for Use
9 17340007000284 4017-04 GEX Powered Laser Surgical Instrument 2 Laser Applicator Non-cooled
10 17340007000277 4017-03 GEX Powered Laser Surgical Instrument 2 Laser Applicator Non-cooled
11 17340007000178 4012-01 GEX Powered Laser Surgical Instrument Laser Applicator Non-cooled
12 17340007000109 3203-01 GEX Powered Laser Surgical Instrument Tissue Temp Probe
13 17340007000093 3103-02 GEX Powered Laser Surgical Instrument Tissue Temp Probe
14 17340007000086 3103-01 GEX Powered Laser Surgical Instrument Tissue Temp Probe
15 17340007000079 3202-01 GEX Powered Laser Surgical Instrument Tissue Temp Probe
16 17340007000062 3102-02 GEX Powered Laser Surgical Instrument Tissue Temp Probe
17 17340007000055 3102-01 GEX Powered Laser Surgical Instrument Tissue Temp Probe
18 17340007000048 3201-01 GEX Powered Laser Surgical Instrument Tissue Temp Probe
19 17340007000031 3101-02 GEX Powered Laser Surgical Instrument Tissue Temp Probe
20 17340007000024 3101-01 GEX Powered Laser Surgical Instrument Tissue Temp Probe
21 17340007000017 1001-01 GEX Powered Laser Surgical Instrument 2 Mobile Laser Unit
22 17340007000468 4017-02 GEX Powered Laser Surgical Instrument 2 Laser Applicator Non-cooled
23 17340007000451 4017-01 GEX Powered Laser Surgical Instrument 2 Laser Applicator Non-cooled
24 17340007000147 4002-01 GEX Powered Laser Surgical Instrument 2 Protection Goggles
25 17340007000543 4018-01 GEX Powered Laser Surgical Instrument 2 Foot Pedal
26 17340007000505 L-2015-049 GEX Powered Laser Surgical Instrument 2 Laser Applicator Non-cooled Instructions for Use
27 17340007000161 4009-01 GEX Powered Laser Surgical Instrument 2 Trolley
28 17340007000475 4013-05 GEA Cannula, Surgical, General & Plastic Surgery MR Cannula
29 17340007000130 4001-03 GEX Powered Laser Surgical Instrument 2 Mains Cable US
30 17340007000536 4013-07 GEA Cannula, Surgical, General & Plastic Surgery 1 MR Adapter TRP-IV
31 17340007000154 4003-01 GEX Powered Laser Surgical Instrument 2 Laser Warning Sign
Other products with the same Product Code "GEX"
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
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