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510(k) Data Aggregation

    K Number
    K251825
    Device Name
    Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co.,Ltd.
    Date Cleared
    2025-10-01

    (110 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K223919,K210948,K240089
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Jmoon FlexGlow Light Therapy Device is an over the counter device that is intended:

    • the Red light and Infrared light is indicated for use in the treatment of full face wrinkles,
    • the Blue light and Red light indicated for the treatment of mild to moderate inflammatory acne.
    Device Description

    Jmoon FlexGlow Light Therapy Device is an exclusive mirrored tabletop device that contains 464 LEDs. It utilizes LED(light-emitting diode) technology to emit energy in the blue, red and near-infrared spectra for the aim to improve the skin appearance, helping to reduce wrinkles, like fine lines and crow's feet, and treat mild to moderate inflammatory acne. The specific wavelengths of light can act on different skin layers to produce different photobiological effects. The device is to be used at 1 cm distance.The flexible and foldable device unit is designed to be placed on a table for easy exposure to the face and body to ensure consistent light treatment. There are three modes: Acne defense Mode(M01), Anti-wrinkle recovery Mode(M02) and Dual care Mode(M03).

    AI/ML Overview

    N/A

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