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

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

    K Number: K864946 · Decision Jan 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    6
    Review Days
    407

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    Basic Information

    Device Name
    ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
    K Number
    K864946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Bio Quantum Technologies, Inc.
    Date Received
    December 17, 1986
    Decision Date
    January 28, 1988
    Product Code
    HHR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HHR Laser, Surgical, Gynecologic

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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
    K864887 ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU
    K864948 ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE
    K840406 MICROSURGICAL CO2 LASER SYS - 4100
    K837110 MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM