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510(k) Data Aggregation

    K Number
    K250880
    Device Name
    LED LIGHT MASK (A093)
    Manufacturer
    Foshan Guangyu Weilai Medical Equipment Co., Ltd.
    Date Cleared
    2025-06-20

    (88 days)

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

    Foshan Guangyu Weilai Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Red light: Treatment of full-face wrinkles. - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
    Device Description
    The LED LIGHT MASK adopts light emitting diodes (LED) in the red (635nm ± 5nm) + blue (425 ± 5nm) and red-blue (635nm + 425nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect (i.e. treatment of wrinkles and mild to moderate acne. The LED LIGHT MASK adopts the form of a mask that contains 64 LEDs on the inner surface of the main unit. A wired controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). The subject device operates in three treatment modes. One mode emits red light, one mode emits blue light, and the third mode emits red-blue light (i.e. mixed light). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, the user must wear the product before turning it on, then the built-in eye mask of the face mask can block the radiation of LED light to the eyes during each treatment.
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