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    K Number
    K081477
    Device Name
    LUXTEC MLX LIGHT SOURCE
    Manufacturer
    INTEGRA LUXTEC, INC.
    Date Cleared
    2008-06-18

    (22 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA LUXTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure. The Integra Luxtec MLX Light Source should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye.
    Device Description
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