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

    MICROSURGICAL CO2 LASER SYS - 4100

    K Number: K840406 · Decision Aug 20, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    6
    Review Days
    202

    Basic Information

    Device Name
    MICROSURGICAL CO2 LASER SYS - 4100
    K Number
    K840406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    BIO QUANTUM TECHNOLOGIES, INC.
    Date Received
    January 31, 1984
    Decision Date
    August 20, 1984
    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 BIO QUANTUM TECHNOLOGIES, INC.

    K Number Device Name
    K934089 BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S
    K864946 ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
    K864887 ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU
    K864948 ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE
    K837110 MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM