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510(k) Data Aggregation

    K Number
    K150716
    Device Name
    Varaya Sport
    Date Cleared
    2015-12-08

    (264 days)

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

    VARAYA PHOTOCEUTICALS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Varaya Sport Mode 200 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The Varaya Sport (Model 200) is a therapeutic device utilizing high-powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs in the device are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adaptor. Recommended treatment time is 10-15 minutes per use.
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    K Number
    K112494
    Device Name
    VARAYA AR , VARAYA SPORT
    Date Cleared
    2012-05-16

    (261 days)

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

    VARAYA PHOTOCEUTICALS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Varava Sport Model 200 is indicated/intended for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The Varaya Sport Model 200 utilizes high powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and a control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adapter.
    Ask a Question

    Ask a specific question about this device

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