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510(k) Data Aggregation

    K Number
    K252189
    Device Name
    LED Light Therapy Mask (2311, 2344, 2457, 2458)
    Manufacturer
    Dongguan Yanxi Technology Co., Ltd.
    Date Cleared
    2025-09-12

    (60 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K241857,K190443,K251042,K230351,K243040
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K241857, K190443

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Red light: Treatment of full-face wrinkles(suitable for model 2344 and model 2457).
    Amber light: Treatment of full-face wrinkles.
    Blue light: Treatment of mild to moderate inflammatory acne.
    Red+Infrared Light: Treatment of full-face wrinkles.

    Device Description

    The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (630nm±5nm), blue (460nm±5nm), amber (605nm±5nm) and infrared (850nm±10nm) spectrum to irradiate on the face to realize its therapeutic effect. The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color), select energy level and adjust time. 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, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.

    AI/ML Overview

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