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510(k) Data Aggregation

    K Number
    K110558
    Device Name
    CS1000 LIGHT THERAPY DEVICE
    Date Cleared
    2012-07-12

    (500 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENESIS HEALTH LIGHT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Genesis Health Light's CS1000 Light Therapy Device is a hand held device used for the treatment of pain by emitting energy in the near IR spectrum for the temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    Genesis Health Light's CS1000 Light-based heat Therapy Device is a hand held device used for the treatment of pain. The primary components of the device are a motor and fan, light bulb, lens and the plastic injection molded housing which encapsulates the device. Cooling liquid is located within the lens assembly. An electric cable is attached to the internal workings of the device and it plugs into a standard 120V electrical outlet to power the device.
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