Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K254079

    Validate with FDA (Live)

    Date Cleared
    2026-03-16

    (88 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    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.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K252994

    Validate with FDA (Live)

    Date Cleared
    2025-12-08

    (81 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K242151

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

    ACNE mode (red light + blue light): Treatment of mild to moderate inflammatory acne.
    FIRM mode (yellow light): Treatment of full-face wrinkles.
    WRINKLE mode (red light + IR light): Treatment of full-face wrinkles.

    Device Description

    The LED Therapy Mask (Models: SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) is an Over-the-Counter (OTC), home-use, wearable LED phototherapy device, and intended for the use of treating full-face wrinkles and mild to moderate acne. Light radiates from the inner surface of the device onto the face. This light is generated by LED with four different spectrum wavelengths: red (630nm), infrared (830nm), yellow (590nm) and blue (415nm). The LED Therapy Mask is consisting of main unit (mask, including eye shield), controller, USB charging cable and head strap.

    The device is powered by rechargeable Li-battery and controlled by a controller that is connected to the main unit. The device's power-on/off, mode switch can be operated by the controller. The device will automatically shut down when the treatment time is over.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1