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510(k) Data Aggregation

    K Number
    K073681
    Device Name
    NANOBEAM 940, MODEL 940-900-02
    Manufacturer
    DAVARAY, INC.
    Date Cleared
    2008-12-09

    (347 days)

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

    DAVARAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indicated use of the Nanobeam 940 is to emit energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
    Device Description
    DavaRay's Nanobeam 940 is a near-infrared light device used for therapeutic purposes. The proposed classification for the new device is Class II. The Nanobeam 940 falls within the definition of a "Sec. 890.5500 Infrared Lamp" Class II device.
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