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510(k) Data Aggregation

    K Number
    K213524
    Device Name
    CytonPro-5000
    Manufacturer
    Cytonsys Inc
    Date Cleared
    2022-08-10

    (280 days)

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

    Cytonsys Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The model CytonPro-5000 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 CytonPro-5000 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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