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

    IRIS OCULIGHT(TM) SL

    K Number: K894841 · Decision Oct 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    10
    Review Days
    66

    Basic Information

    Device Name
    IRIS OCULIGHT(TM) SL
    K Number
    K894841
    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
    July 31, 1989
    Decision Date
    October 5, 1989
    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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    Other Clearances by IRIDERM DIV.

    K Number Device Name
    K964074 DIOLITE 532
    K960971 OCULIGHT GL
    K960522 DIOPEXY PROBE
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    K933211 D'AMICO\PEYMAN FLUTED ENDOPROBE
    K922663 IRIS OCULIGHT SL
    K913430 IRIS OCULIGHT(R) SLX
    K912918 IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER
    K903288 IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED