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
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    10
    Review Days
    66

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.

    Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PICOSURE WORKSTATION

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LumiGlam Laser System (SHE-LSP601-3)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LASEmaR 1500

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LUNE PureHygiene

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Boston 2910 (Boston 2910)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Iriderm Div.

    K Number Device Name
    K964074 DIOLITE 532
    K960971 OCULIGHT GL
    K960522 DIOPEXY PROBE
    K915236 IRIS G-PROBE
    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