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510(k) Data Aggregation

    K Number
    K132529
    Device Name
    GALLIEON-1 MEDICAL LASER
    Date Cleared
    2014-05-12

    (273 days)

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

    FUTURE DEVICE AND TECHNOLOGY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gallieon-1 system is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for - . the temporary relief of minor muscle and joint pain and stiffness - . relief of minor pain and stiffness associated with arthritis - relief of muscle spasm ● - the temporary increase in local blood circulation - . promoting relaxation of muscle/ligament The Gallieon -1 SYSTEM is for prescription use only. The device is indicated for emitting energy in the infrared spectrum to provide topical heating tissue temperature for temporary relief of minor muscle spasm, pain and stiffhess associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
    Device Description
    Gallieon-1 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy in the health care centers, physical therapy laboratories, and family practices. It is composed of adjustable output powers, handpiece (emitter) for the delivery of light, on/off button to activate and deactivate the infrared emission. Also Gallieon-1 meets FDA requirement of the skin temperature test and the electromagnetic compatibility and electrical safety test.
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