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510(k) Data Aggregation

    K Number
    K981090
    Device Name
    LASERLITE DIODE SURGICAL LASER
    Manufacturer
    LASERLITE, LLC.
    Date Cleared
    1998-04-21

    (26 days)

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

    LASERLITE, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LaserLite Diode Surgical Laser is intended for treatment of pigmented and vascular lesions including leg veins.
    Device Description
    The LaserLite Diode Laser System is a semiconductor diode laser operating at 810 + 20 microns.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    LASERLITE, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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