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510(k) Data Aggregation

    K Number
    K252093
    Device Name
    Light Therapy Mask (1019055)
    Manufacturer
    Merchsource LLC
    Date Cleared
    2025-10-16

    (105 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K243040,K210545,K163329,K223544,K241857
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Light Therapy Mask is an over-the-counter device intended for the treatment of full-face wrinkles and mild to moderate inflammatory acne using LED light therapy.

    • Red light: Treatment of full-face wrinkles.
    • Blue light: Treatment of mild to moderate inflammatory acne.
    • Red+Infrared Light: Treatment of full-face wrinkles.
    • Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.
    Device Description

    The subject device Light Therapy Mask is a home use wearable LED phototherapy device whose purpose is to produce an even and narrow-band of light for the treatment of aesthetic indications including facial wrinkles and acnes.

    The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and USB-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.

    The LEDs generate 3 kinds of light which include Red light (wavelength 635nm±5nm), Blue light (wavelength 465nm±5nm), Infrared light (wavelength 850nm±5nm). A controller is connect to the mask body unit to control the device, such as turn on/off the device. And the straps used for securing the mask unit to the body part.

    The device have vibration function, and user can adjust the vibration intensity. Vibration is for general relaxation purposes.

    AI/ML Overview

    N/A

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