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510(k) Data Aggregation

    K Number
    K252264
    Device Name
    MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)
    Manufacturer
    Shenzhen Zhenxing Ruitong Technology Co., Ltd.
    Date Cleared
    2025-10-17

    (88 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K223544,K171647,K230351,K242385
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K223544, K171647

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

    The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device.

    • Red light: Treatment of full-face wrinkles.
    • Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne.
    Device Description

    The MEGELIN LED Light Therapy Mask uses blue light (460nm) to treat acne. The MEGELIN LED Light Therapy Mask uses red light (660nm) to irradiate on the facial skin that help reduce wrinkles.

    JML1, JML3, JML5, JML6, JML9 are face masks, with the only difference in energy density setting, while JML2, JML4, JML7, JML8, JML10 are neck masks with the only difference in energy density setting.

    AI/ML Overview

    N/A

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