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510(k) Data Aggregation

    K Number
    K024027
    Device Name
    LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
    Date Cleared
    2003-12-03

    (362 days)

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

    SKYTECH ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide infrared light energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion
    Device Description
    The devices are a family (models) of infrared lamps having the same indication for use and equivalent technology. The units are electrical and mechanical designs for use and convenience of users to provide topical heating. Heat is generated by LEDs (light emitting diodes) at 940 nm wavelength.
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