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510(k) Data Aggregation

    K Number
    K960867
    Device Name
    FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532)
    Manufacturer
    B.V. INTL. S.A.
    Date Cleared
    1996-05-14

    (71 days)

    Product Code
    GEX, 86H
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    B.V. INTL. S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used with a slit lamp adaptor, this system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including : Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment.
    Device Description
    The laser source is an Nd: YAG Slab, pumped by a Laser Diode (810 nm), with a frequency doubling crystal (KTP). The treatment beam is delivered through a delivery system and is aimed using a Red Laser Diode (670 nm). The 3 possible delivery systems are the followirig : - Slit lamp adaptor - Indirect ophthalmoscope adaptor - Endocular probe adaptor Output power of all these delivery systems have a maximum of 1.5 Watts.
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