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510(k) Data Aggregation

    K Number
    K253878

    Validate with FDA (Live)

    Device Name
    LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Date Cleared
    2026-03-04

    (90 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K160691,K230720
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LUSTRE GoGlow Advanced LED Patches (Model: PR8001, PR9001) is an Over-the-Counter (OTC) device that emits energy in the blue and red spectrum for the treatment of mild to moderate inflammatory acne.

    Device Description

    The LUSTRE GoGlow Advanced LED Patches (Model: PR8001, PR9001) is an over-the-counter light emitting diode (LED) device indicated for the treatment of mild to moderate acne. It works by emitting energy in the blue (415nm) and red (630nm) spectrum. Each patch incorporates 24 LEDs with a power intensity of approximately 30 mW/cm². The two models differ only in shape: the PR9001 is triangle, while the PR8001 is bean-shaped.

    The device package includes two LED patches, two rechargeable controllers, a charging case, a USB cable, 56 Mini Dots(for holding the patch safely to the skin), a pair of goggles and a user manual. To use, simply connect a controller to each patch via the built-in magnets, apply the patches to the targeted skin area using the Mini Dots, then press and hold the power button on the controller to activate the device and start the treatment session. The patches will automatically shut off after the 3-minute session is complete.

    AI/ML Overview

    N/A

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