BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED

    K Number: K903288 · Decision Sep 24, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    10
    Review Days
    88

    Basic Information

    Device Name
    IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED
    K Number
    K903288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    IRIDERM DIV.
    Date Received
    June 28, 1990
    Decision Date
    September 24, 1990
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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