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510(k) Data Aggregation

    K Number
    K254079

    Validate with FDA (Live)

    Device Name
    LED Light Therapy Mask (Models: T2, RLD10)
    Manufacturer
    Shenzhen Desida Technology Co., Ltd.
    Date Cleared
    2026-03-16

    (88 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K230351,K242151,K250830,K242796,K241857
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Red+Infrared light: Treatment of full-face wrinkles.
    • Blue light: Treatment of mild to moderate inflammatory acne.
    • Mixed light (Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne.
    Device Description

    LED Light Therapy Mask (Models: T2, RLD10) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne. LED Light Therapy Mask consists of main unit (mask, safety goggles), controller, Type-C charging cable and straps. There are 3 kinds of light, which include Red light (wavelength 630nm), Blue light (wavelength 470nm), Infrared light (wavelength 850nm). All models can output 3 kinds of treatment modes: red+infrared, blue and red+infrared+blue light.

    AI/ML Overview

    N/A

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