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510(k) Data Aggregation

    K Number
    K150554
    Device Name
    NuBrilliance Light Pain Therapy
    Manufacturer
    WELLQUEST INTERNATIONAL, INC.
    Date Cleared
    2015-10-06

    (216 days)

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

    WELLQUEST INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nu Brilliance Light Pain Therapy system is an Over-The-Counter handheld device intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
    Device Description
    The NuBrilliance Light Pain Therapy device is a lightweight, light emitting diode (LED) device that emits light energy. The NuBrilliance Light Pain Therapy device is an Over-The-Counter (OTC), hand held, ergonomically designed pain relief device that uses the infrared lamp for therapeutic heating. The head consists of four (#4) visible diodes (red lights) in the 625 nm (±5%) spectrum, and (#56) fifty-six infrared diodes (purple lights) in the 940 nm (±5%) spectrum that are used in combination for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature. Treatment is controlled by the operator. There are no user settings or adjustments.
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