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510(k) Data Aggregation

    K Number
    K032379
    Device Name
    QUASAR, MODEL MD21
    Date Cleared
    2003-11-20

    (111 days)

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

    QUANTUM SKINCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quasar MD21 infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
    Device Description
    The Quasar MD21 consists of a collection of both infrared and red diodes [LEDs], packaged in a compact plastic head. The system emits pulsed light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. For operation turn on LEDs for a time period of twenty-five (25) minutes prior to use.
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