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510(k) Data Aggregation

    K Number
    K980142
    Device Name
    FEATHERLITE DIODE LASER
    Manufacturer
    LASERLITE, LLC.
    Date Cleared
    1998-04-03

    (78 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K962354
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LaserLite diode surgical laser is indicated for incision, excision, vaporization, ablation, cutting, hemostasis and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.

    Device Description

    The LaserLite diode surgical laser is a semiconductor diode laser operating at 810 + 20 microns.

    AI/ML Overview

    The provided 510(k) summary for the LaserLite Diode Surgical Laser explicitly states "Performance data: None." It explains that because the specifications and indications for use are "the same or very similar" to legally marketed predicate devices (e.g., Diomed Diode 60W laser K962354), and it has no additional indications for use, performance data was not required.

    Therefore, there is no information in the provided document about acceptance criteria or a study proving the device meets them. This submission relies on substantial equivalence to predicate devices rather than new performance data.

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