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

    ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE

    K Number: K864948 · Decision Mar 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    6
    Review Days
    103

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    Basic Information

    Device Name
    ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE
    K Number
    K864948
    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
    December 17, 1986
    Decision Date
    March 30, 1987
    Product Code
    LNK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNK Laser For Gastro-Urology Use

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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
    K840406 MICROSURGICAL CO2 LASER SYS - 4100
    K837110 MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM