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

    ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU

    K Number: K864887 · Decision Apr 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    6
    Review Days
    119

    Basic Information

    Device Name
    ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU
    K Number
    K864887
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    BIO QUANTUM TECHNOLOGIES, INC.
    Date Received
    December 12, 1986
    Decision Date
    April 10, 1987
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.

    AviClear Laser System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Pastelle

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SurgiLight 1470 Diode Laser System (Model:Halo)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AuroLase® System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Diode laser device (RF3120-BI)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

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