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

    DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50

    K Number: K991464 · Decision Jul 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    4
    Review Days
    84

    Basic Information

    Device Name
    DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50
    K Number
    K991464
    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
    FISMA, INC.
    Date Received
    April 27, 1999
    Decision Date
    July 20, 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 FISMA, INC.

    K Number Device Name
    K000158 VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
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    K963124 PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)