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510(k) Data Aggregation

    K Number
    K254079

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    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
    Why did this record match?
    Reference Devices :

    K230351, K242151, K250830, K242796

    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.

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    K Number
    K252053

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    Device Name
    VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
    Manufacturer
    TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD
    Date Cleared
    2025-10-27

    (118 days)

    Product Code
    OHS,OAP,OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K250830,K213789,K230597,K190443
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K250830

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

    VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device.

    Head Mode: The device is indicated to promote hair growth in male with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic aplopecia who have Ludwig-Savin Classification of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.

    Face Mode:
    LED therapy function: The device is indicated for the treatment of full face wrinkles and/or mild to moderate inflammatory acne.

    Device Description

    The VITA Multi-Function Head Brush is a hand-held device. It consists of a host, a removable treatment head, and a charging cable. The host has a button, indicator lights, and the device's power-on/off, treatment mode switch can be achieved by pressing the button. The removable treatment head has lights row, stainless steel bristles and liquid reservoir (applicable for model TB-2443F/ TB-2442AF), of which the liquid reservoir is used for the hair care after treatment.

    The LEDs and low-level lasers in the removable treatment head emit light on the treatment area. In addition, the device is also equipped with a built-in micro motor to generates micro-vibration to relax the facial skin. The device has a head mode and face mode, and the device will automatically shut down after each mode completes treatment within 10 minutes. The device is powered by a built-in rechargeable lithium battery.

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