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510(k) Data Aggregation

    K Number
    K132833
    Device Name
    ULTRA RENEW PLUS
    Manufacturer
    ACCORD MEDIA
    Date Cleared
    2014-06-17

    (280 days)

    Product Code
    OLP, ISA, OHS
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCORD MEDIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accord Media Ultra Renew Plus is intended to be used: LED functional mode - To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face. - To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles. Ultrasonic functional mode - As an electrically powered device intended for medical purposes to relieve minor aches and pains.
    Device Description
    The Ultra Renew Plus is a hand held, mains powered, device used for the treatment of acne, periorbital wrinkles, and the relief of minor aches and pains. The Ultra Renew Plus combines two (2) functional modes of operation, LED and ultrasonic. The LED functional mode provides narrow bandwidth spectral output in the blue (415 ± 5 nm) and red (650 ± 5 nm) ranges. The ultrasonic functional mode operates at a fixed frequency of 3 MHz ± 5%. The Ultra Renew Plus uses a supplied power adaptor.
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