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510(k) Data Aggregation

    K Number
    K253712

    Validate with FDA (Live)

    Device Name
    LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)
    Manufacturer
    Shenzhen Rainbow Technology Co., Ltd.
    Date Cleared
    2026-01-23

    (60 days)

    Product Code
    OHS,ILY,OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    22 - 120
    Reference & Predicate Devices
    K230042,K241857,K230351,K242796,K243423
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K230042, K241857, K230351, K242796

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    *Red+Infrared light: Treatment of full-face wrinkles.
    *Red light: Treatment of full-face wrinkles.
    *Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm;relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
    *Blue light: Treatment of mild to moderate inflammatory acne.
    *Red+Blue light: Treatment of mild to moderate inflammatory acne.
    The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.

    Device Description

    LED Light Therapy Mask (Model: RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Mask is consisting of main unit(mask), controller, Type-C charging cable and so on. There are 3 kinds of light, which include Red light (wavelength 630nm), Blue light (wavelength 465nm), Infrared light (wavelength 850nm). All models can output 5 kinds of treatment modes: red+infrared, red, infrared, blue and red+blue light.

    AI/ML Overview

    N/A

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