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

    ACCU-BEAM C02 LASER HANDPIECE

    K Number: K945648 · Decision Feb 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    9
    Review Days
    99

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    Basic Information

    Device Name
    ACCU-BEAM C02 LASER HANDPIECE
    K Number
    K945648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tti Medical
    Date Received
    November 17, 1994
    Decision Date
    February 24, 1995
    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 Tti Medical

    K Number Device Name
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    K921208 ACCU-BEAM TUBE SET
    K910978 ACCU-BEAM LAPAROSCOPIC SYSTEM
    K895656 ACCU-BEAM WAVEGUIDE
    K890922 ACCU-BEAM YAG FIBER
    K870063 CO2 LASER BRONCHOSCOPE SET
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