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

    EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS

    K Number: K041957 · Decision Dec 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    5
    Review Days
    133

    Basic Information

    Device Name
    EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
    K Number
    K041957
    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
    DIOMED, INC.
    Date Received
    July 21, 2004
    Decision Date
    December 1, 2004
    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 DIOMED, INC.

    K Number Device Name
    K023543 EVLT KIT AND D15PLUS AND D30PLUS DIODE
    K013499 DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
    K000982 A100 AESTHETIC DIODE LASER
    K990014 DIOSCAN