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    K Number
    K080084
    Device Name
    CELL GEN LASER, MODEL CG-4000
    Manufacturer
    CELL GEN THERAPEUTICS, LLC
    Date Cleared
    2008-04-21

    (101 days)

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

    CELL GEN THERAPEUTICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The model CG-4000 Cell Gen laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.
    Device Description
    The Cell Gen CG-4000 laser is a non-invasive, diode laser system consisting of an enclosure which contains the control unit and a treatment probe connected by an optic fiber.
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