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

    CYBER-LASE 2000 CURING AND WHITENING LASER

    K Number: K983654 · Decision Jan 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    2
    Review Days
    85

    Basic Information

    Device Name
    CYBER-LASE 2000 CURING AND WHITENING LASER
    K Number
    K983654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ICS OF NORTH AMERICA, INC.
    Date Received
    October 19, 1998
    Decision Date
    January 12, 1999
    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 ICS OF NORTH AMERICA, INC.

    K Number Device Name
    K992357 EASY-CURE (CURING AND WHITENING LIGHT)