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510(k) Data Aggregation

    K Number
    K152722
    Device Name
    neoV980 & neoV1470 Diode Lasers
    Manufacturer
    G.N.S NEO LASER LTD.
    Date Cleared
    2015-12-08

    (77 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    G.N.S NEO LASER LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The neoV980 & neoV1470 Diode Lasers, (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation, and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.
    Device Description
    neoV980 & neoV1470, members of the neoV Diode Lasers family, cleared under K133006, are medical grade, solid-state, infrared Diode lasers, designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980nm and 1470nm respectively, with power level ranging from 10 to 20 Watts respectively. The lasers are controlled via a high-resolution color touch screen. The touch screen display includes a user interface allowing selection of continuous, repeat pulse, or single pulse modes of operation as well as repetition rates, aiming beam settings, password key protection, and standby/ready mode selection. The units have an emergency shut off button on the front of the unit. The Laser System: The laser system consists of an optical block which contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and electronics which include the color touch screen control panel. The unit utilizes an external low voltage power supply, as well as an external wired foot switch for laser activation. The Delivery System: The delivery system consists of either sterile fibers (not provided with the system) or non-sterile fibers and hand pieces. Safety goggles, non sterile fibers, handpieces and a safety sign are provided with the unit.
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