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

    MODEL 545-45 LASER FOR DERMA., POD., SURGICAL

    K Number: K860974 · Decision Jul 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    17
    Review Days
    115

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    Basic Information

    Device Name
    MODEL 545-45 LASER FOR DERMA., POD., SURGICAL
    K Number
    K860974
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Britt Corp., Inc.
    Date Received
    March 14, 1986
    Decision Date
    July 7, 1986
    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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    K860977 MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
    K860975 MODEL 545-45 LASER FOR EAR, NOSE & THROAT
    K860277 MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT
    K860273 MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY
    K860278 MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC
    K851425 MODEL J25-25 WATT CO2 LASER
    K840020 FITNESS LOGGER
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