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510(k) Data Aggregation

    K Number
    K201171
    Device Name
    LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
    Date Cleared
    2021-04-02

    (336 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEONI Fiber Optics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LEONI™ Laser Fibers (BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable) are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors and are indicated for use in laser-based surgical applications and procedures that are performed with compatible lasers operating at wavelengths between 500nm and 2200nm, which have been cleared.
    Device Description
    The fiber optic delivery systems are accessories designed to deliver optical energy to soft or fibrous tissue in general surgical applications, in combination with any SMA-compatible laser system also indicated for the same applications. They are composed of silicon, polyimide, acrylate, and polyamide. The device systems are available in multiple sizes and with multiple tip shapes and handpiece configurations. The fiber optics are available in reusable, and single use disposable devices that are prepackaged sterile. The reusable fiber optic systems may be reused only after the optical fiber tip is cleaned according to the Instructions for Use.
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