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

    LASEGUIDE 600A, 600B, 400A, AND 400B

    K Number: K874680 · Decision Mar 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    9
    Applicant Total
    12
    Review Days
    131

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    Basic Information

    Device Name
    LASEGUIDE 600A, 600B, 400A, AND 400B
    K Number
    K874680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Laser Peripherals, LLC
    Date Received
    November 13, 1987
    Decision Date
    March 23, 1988
    Product Code
    FCS
    Advisory Committee
    Gastroenterology, Urology
    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
    FCS Light, Catheter, Fiberoptic, Glass, Ureteral

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    Other Clearances by Laser Peripherals, LLC

    K Number Device Name
    K170366 Laser Peripherals, LLC Family of Bare Laser Fibers
    K030959 BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
    K011207 LASER PERIPHERALS REUSABLE HOLMIUM FIBER
    K992083 SCATTERFREE LATERAL EMITTING FIBER
    K974229 LS-905 FIBERCHOICE ADAPTER SYSTEM
    K972272 LASER PERIPHERALS HOLMIUM BARE FIBERS
    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
    Search all 12 clearances from Laser Peripherals, LLC →