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510(k) Data Aggregation

    K Number
    K072399
    Device Name
    DEL SOL RED LIGHT THERAPY SYSTEM
    Manufacturer
    Date Cleared
    2008-05-23

    (270 days)

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

    EDGE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Del Sol Red Light Therapy System is intended to emit energy in the near infrared spectrum (880nm) 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
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