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    K Number
    K061117
    Device Name
    NANOLITE SKIN CARE SYSTEM
    Manufacturer
    NANOLITE TECHNOLOGY, INC.
    Date Cleared
    2006-06-20

    (60 days)

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

    NANOLITE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nanolite Skin Care System is indicated to treat pigmented lesions.
    Device Description
    The Nanolite Skin Care System is a light-based device that uses LED to stimulate and regenerate skin cells. The device delivers red light at 640 nm. The principal parts of the device are: the base that contains the power supply; a LED module containing surface mount device chip LEDs; one arm attached to the LED module to be positioned for patient treatment; and a control unit consisting of an LCD panel with a touchscreen display.
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