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

    LASER PERIPHERALS HOLMIUM BARE FIBERS

    K Number: K972272 · Decision Jul 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    10
    Review Days
    41

    Basic Information

    Device Name
    LASER PERIPHERALS HOLMIUM BARE FIBERS
    K Number
    K972272
    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
    LASER PERIPHERALS LLC.
    Date Received
    June 18, 1997
    Decision Date
    July 29, 1997
    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 LASER PERIPHERALS LLC.

    K Number Device Name
    K030959 BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
    K992083 SCATTERFREE LATERAL EMITTING FIBER
    K974229 LS-905 FIBERCHOICE ADAPTER SYSTEM
    K961516 LASER PERIPHERALS INC. BARE FIBER
    K961079 LASER PERIPHERALS INC. SCATTERFREE FIBER
    K901786 LASEGUIDE CAT # CLF-600D & CLF-1000D
    K880591 LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE
    K880592 LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE
    K874680 LASEGUIDE 600A, 600B, 400A, AND 400B