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510(k) Data Aggregation

    K Number
    K214103
    Device Name
    Shani Darden LED light therapy mask
    Manufacturer
    Harpar Grace International
    Date Cleared
    2022-03-22

    (83 days)

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

    Harpar Grace International

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
    Device Description
    The Shani Darden LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face. The system consists of a hard-shell mask and a controller. The mask is worn on the face and is held in place by an adjustable Velcro strap. The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm.). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller allows the user to select one of three treatment programmes (acne and wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The controller contains a simple graphical user interface (GUI) and three control buttons. The mask receives its power from a mains power adaptor.
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