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510(k) Data Aggregation

    K Number
    K252994

    Validate with FDA (Live)

    Device Name
    LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
    Manufacturer
    Guangdong Ace-Tec Co., Ltd.
    Date Cleared
    2025-12-08

    (81 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K242151,K242796,K231555,K240089
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ACNE mode (red light + blue light): Treatment of mild to moderate inflammatory acne.
    FIRM mode (yellow light): Treatment of full-face wrinkles.
    WRINKLE mode (red light + IR light): Treatment of full-face wrinkles.

    Device Description

    The LED Therapy Mask (Models: SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) 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 (630nm), infrared (830nm), yellow (590nm) and blue (415nm). The LED Therapy Mask is consisting of main unit (mask, including eye shield), controller, USB charging cable and head strap.

    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 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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