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

    SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION)

    K Number: K890174 · Decision Jan 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    51
    Review Days
    17

    Basic Information

    Device Name
    SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION)
    K Number
    K890174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    SURGICAL LASER TECHNOLOGIES, INC.
    Date Received
    January 9, 1989
    Decision Date
    January 26, 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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