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

    LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE

    K Number: K880591 · Decision Jun 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    12
    Review Days
    111

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    Basic Information

    Device Name
    LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE
    K Number
    K880591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Laser Peripherals, LLC
    Date Received
    February 11, 1988
    Decision Date
    June 1, 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 Laser Peripherals, LLC

    K Number Device Name
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    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
    K880592 LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE
    Search all 12 clearances from Laser Peripherals, LLC →