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

    LS-905 FIBERCHOICE ADAPTER SYSTEM

    K Number: K974229 · Decision Feb 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    10
    Review Days
    90

    Basic Information

    Device Name
    LS-905 FIBERCHOICE ADAPTER SYSTEM
    K Number
    K974229
    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
    November 12, 1997
    Decision Date
    February 10, 1998
    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

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    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
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