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510(k) Data Aggregation

    K Number
    K210954
    Device Name
    Synergy
    Manufacturer
    YRS Group Inc.
    Date Cleared
    2021-06-29

    (91 days)

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

    YRS Group Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
    Device Description
    The SYNERGY is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and infrared spectrum for the treatment of wrinkles on the face. The SYNERGY components include an applicator, a charging station and an adaptor. The treatment surface is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user repairable components. The device is sold for Over the Counter (OTC) use.
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