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510(k) Data Aggregation

    K Number
    K252983

    Validate with FDA (Live)

    Device Name
    Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
    Manufacturer
    Shenzhen Goodwind Technology Development Co., Ltd.
    Date Cleared
    2025-12-17

    (90 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K233556,K230042,K233114
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wrinkle Retreat Pro Light Therapy Face Mask is an Over-the-Counter (OTC) device intended for use in treating full-face wrinkles.

    Device Description

    The Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) adopts light emitting diodes (LED) in amber(605nm±5nm), red (630nm±5nm), red (660nm±5nm) and near-infrared (830nm±5nm) spectrum to irradiate on the face to realize its therapeutic effect. The Wrinkle Retreat Pro Light Therapy Face 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 to turn on/off the device. 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, this Mask has incorporated protective eye-shield which blocks light energy from LEDs. The Mask is powered by a built-in rechargeable lithium battery which is located in the controller.

    AI/ML Overview

    N/A

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