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510(k) Data Aggregation

    K Number
    K214101
    Device Name
    Project E Beauty LED Light Therapy Mask (Model: PE730)
    Date Cleared
    2022-03-23

    (84 days)

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

    Duplex International Trading Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Project E Beauty LED Light Therapy Mask is an over the counter device that is indicated for the treatment of full face wrinkles and mild to moderate acne.
    Device Description
    The Project E Beauty LED Light Therapy Mask is a facemask-shaped device designed for home-use, which uses Light Emitting Diodes to emit energy in the red, blue and infrared region of the spectrum. The Project E Beauty LED Light Therapy Mask has a total of 36 LEDs. The red light with wavelengths centered at 635-644nm and the infrared light with wavelengths centered at 845-855nm to treat wrinkles on the face. The blue light with wavelengths centered at 430-445nm and the red light with wavelengths centered at 635-644nm to treat mild to moderate acne on the face. The Project E Beauty LED Light Therapy Mask components include the LED module, USB power cord, and integrated module. The user wears the device over the face, like a pair of glasses, and presses the Power button on the integrated module for 1 second to initiate the treatment. The device has a continuous working time of 12 minutes and powers off automatically.
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