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510(k) Data Aggregation

    K Number
    K974229
    Device Name
    LS-905 FIBERCHOICE ADAPTER SYSTEM
    Manufacturer
    LASER PERIPHERALS LLC.
    Date Cleared
    1998-02-10

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LS-905 FIBERCHOICE ADAPTER SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LS-905 FiberChoice™ Adapter System is indicated for use for non-standard laser output ports for lasers manufactured by Laserscope. The LS-905 FiberChoice™ Adapter System is designed to allow owners of Laserscope lasers to connect Laser Peripherals, Inc. 510(k) cleared laser fibers to their lasers. The adapter may be used in each surgical specialty or procedure along with Laser Peripherals laser fibers for which compatible Laserscope lasers have received regulatory clearance.

    Device Description

    Not Found

    AI/ML Overview

    The provided document {0} - {2} is a 510(k) clearance letter for the LS-905 FiberChoice Adapter System. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations applicable to the device. However, it does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot generate the requested information based on the provided text.

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