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510(k) Data Aggregation

    K Number
    K252096
    Device Name
    Light Therapy Decollete Mask (1019135)
    Manufacturer
    Merchsource LLC
    Date Cleared
    2025-10-01

    (90 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K242382
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is an over-the-counter device that is intended for use in the treatment of wrinkles in the decolletage area.

    Device Description

    The subject device LIGHT THERAPY DECOLLETE 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 cosmetic indications including facial wrinkles and acnes.

    The subject device consists of a decollete 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 2 kinds of light which include Red light (wavelength 630nm±5nm) and Infrared light (wavelength 850nm±5nm). A controller is connect to the decollete mask body unit to control the device, such as turn on/off the device. And the straps used for securing the decollete mask unit to the body part.

    AI/ML Overview

    N/A

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