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510(k) Data Aggregation

    K Number
    K223147
    Device Name
    myLEDmask
    Manufacturer
    myBlend
    Date Cleared
    2023-05-14

    (221 days)

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

    myBlend

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    myLEDmask is an over-the-counter device that is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.
    Device Description
    MyLEDmask is a device used to perform photobiomodulation (based on lightemitting diode (LED) light) on the face and neck. Light radiates from the inner surface of the device onto the face and neck. This light is generated by LEDs with two different visible spectrum wavelengths: red (630 nm) and near-infrared (850 nm). 3 Care programs (LEDs activation duration) based on 3 skin phototypes (skin tone) are available. - Phototype 1 Fair Skin - - Phototype 2 Moderately Dark Skin - -Phototype 3 Dark Skin At the end of care duration, device will automatically switch off It is operated by a microcontroller and powered by rechargeable batteries with an external independent Charger To prevent irradiation of LED lights to eyes during the treatment, MyLEDmask has protective eye-shield which blocks light energy from LEDs.
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