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510(k) Data Aggregation

    K Number
    K041262
    Device Name
    DURALITE-GL
    Manufacturer
    LASER SCIENTIFIC
    Date Cleared
    2004-08-13

    (94 days)

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

    LASER SCIENTIFIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DuraLite-GL is a replacement fiber optic component for the Candela GentleLASE family of lasers. The DuraLite-GL may be used as a replacement part for ail procedures as cleared by the FDA for the Candela GentleLase family of lasers.
    Device Description
    The DuraLITE-GL is an exact replacement component for the Candela GentleLASE Plus fiber optic.
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