Other products from "OPHTHALMED LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 M735B62B2131 B62B213 HQF Laser, Ophthalmic 2 NA
2 M735B62B1131 B62B113 HQF Laser, Ophthalmic 2 NA
3 M735B6272131 B627213 HQF Laser, Ophthalmic 2 NA
4 M735B6271131 B627113 HQF Laser, Ophthalmic 2 NA
5 M735B6255131 B625513 HQF Laser, Ophthalmic 2 NA
6 M735B62B5131 B62B513 HQF Laser, Ophthalmic 2 NA
7 M735B62B4131 B62B413 HQF Laser, Ophthalmic 2 NA
8 M735B62B3131 B62B313 HQF Laser, Ophthalmic 2 NA
9 M735B62A5131 B62A513 HQF Laser, Ophthalmic 2 NA
10 M735B62A4131 B62A413 HQF Laser, Ophthalmic 2 NA
11 M735B62A3131 B62A313 HQF Laser, Ophthalmic 2 NA
12 M735B62A2131 B62A213 HQF Laser, Ophthalmic 2 NA
13 M735B62A1131 B62A113 HQF Laser, Ophthalmic 2 NA
14 M735B6295131 B629513 HQF Laser, Ophthalmic 2 NA
15 M735B6294131 B629413 HQF Laser, Ophthalmic 2 NA
16 M735B6293131 B629313 HQF Laser, Ophthalmic 2 NA
17 M735B6292131 B629213 HQF Laser, Ophthalmic 2 NA
18 M735B6291131 B629113 HQF Laser, Ophthalmic 2 NA
19 M735B6285131 B628513 HQF Laser, Ophthalmic 2 NA
20 M735B6284131 B628413 HQF Laser, Ophthalmic 2 NA
21 M735B6283131 B628313 HQF Laser, Ophthalmic 2 NA
22 M735B6282131 B628213 HQF Laser, Ophthalmic 2 NA
23 M735B6281131 B628113 HQF Laser, Ophthalmic 2 NA
24 M735B6275131 B627513 HQF Laser, Ophthalmic 2 NA
25 M735B6274131 B627413 HQF Laser, Ophthalmic 2 NA
26 M735B6273131 B627313 HQF Laser, Ophthalmic 2 NA
27 M735B6254131 B624413 HQF Laser, Ophthalmic 2 NA
28 M735B6253131 B625313 HQF Laser, Ophthalmic 2 NA
29 M735B6252131 B625213 HQF Laser, Ophthalmic 2 NA
30 M735B6251131 B625113 HQF Laser, Ophthalmic 2 NA
31 M735B6245131 B624513 HQF Laser, Ophthalmic 2 NA
32 M735B6244131 B624413 HQF Laser, Ophthalmic 2 NA
33 M735B6243131 B624313 HQF Laser, Ophthalmic 2 NA
34 M735B6242131 B624213 HQF Laser, Ophthalmic 2 NA
35 M735B6241131 B624113 HQF Laser, Ophthalmic 2 NA
36 M735B6235131 B623513 HQF Laser, Ophthalmic 2 NA
37 M735B6234131 B623413 HQF Laser, Ophthalmic 2 NA
38 M735B6233131 B623313 HQF Laser, Ophthalmic 2 NA
39 M735B6232131 B623213 HQF Laser, Ophthalmic 2 NA
40 M735B6231131 B623113 HQF Laser, Ophthalmic 2 NA
41 M735B6225131 B622513 HQF Laser, Ophthalmic 2 NA
42 M735B6224131 B622413 HQF Laser, Ophthalmic 2 NA
43 M735B6223131 B622313 HQF Laser, Ophthalmic 2 NA
44 M735B6222131 B622213 HQF Laser, Ophthalmic 2 NA
45 M735B6221131 B622113 HQF Laser, Ophthalmic 2 NA
46 M735B5BB5031 B5BB503 HQF Laser, Ophthalmic 2 NA
47 M735B5BB4031 B5BB403 HQF Laser, Ophthalmic 2 NA
48 M735B5BB3031 B5BB303 HQF Laser, Ophthalmic 2 NA
49 M735B5BB2031 B5BB203 HQF Laser, Ophthalmic 2 NA
50 M735B5BB1031 B5BB103 HQF Laser, Ophthalmic 2 NA
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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