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510(k) Data Aggregation

    K Number
    K253054

    Validate with FDA (Live)

    Device Name
    LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
    Manufacturer
    Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
    Date Cleared
    2025-12-19

    (88 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K242700,K243040,K251588,K242593,K243492,K223544
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is an over the counter device that is intended for:

    • Red+Infrared light: Treatment of full-face wrinkles;
    • Red+Blue+Infrared light: Treatment of mild to moderate inflammatory acne;
    • Yellow+Infrared light: Treatment of full-face wrinkles.
    Device Description

    The LED Light Therapy Mask (Models: M19, M19-1, M19-2, M19-3, M19-5, M19-6) is an Over-the-Counter (OTC), home-use, wearable LED phototherapy device, and intended for the use of treating full-face wrinkles and mild to moderate acne. Light radiates from the inner surface of the device onto the face. This light is generated by LED with four different spectrum wavelengths: red (660nm), infrared (850nm), yellow (590nm) and blue (460nm). The LED Light Therapy Mask is consisting of main unit (mask), controller and USB charging cable. The device is powered by rechargeable Li-battery and controlled by a controller that is connected to the main unit. The device's power-on/off, mode switch, intensity adjustment and time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.

    AI/ML Overview

    N/A

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