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510(k) Data Aggregation

    K Number
    K260511

    Validate with FDA (Live)

    Date Cleared
    2026-03-16

    (27 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    22 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Ulike Reglow Light Therapy Device is an over the counter device that is intended for use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne.

    Device Description

    Ulike Reglow Light Therapy Device adopts 272 light emitting diodes (LED) with the multiwavelength of 630nm±10nm,830nm±10nm,590nm±10nm and 465nm±10nm spectrum to irradiate the facial area to realize its therapeutic effect, including reducing wrinkles and treating mild to moderate inflammatory acne, which improves overall skin appearance.

    The Ulike Reglow Light Therapy Device adopts the form of a mask that contains LEDs on the inner surface of the main unit. The device is with user-friendly operation through a controller which is connected to the main unit to control the device, such as turn on/off the device, switch mode.

    The device offers four selectable operating modes via the external controller:

    • Mode 1 (Glow mode): 630 nm + 830 nm + 590 nm
    • Mode 2 (Anti-Aging mode): 630 nm + 830 nm
    • Mode 3 (Restoring mode): 590 nm + 830 nm
    • Mode 4 (Clear mode): 465 nm + 630 nm + 830 nm

    To use the device, user should place the mask over the face and use the controller to operate. To prevent irradiation of LED lights to eyes during the treatment, Ulike Reglow Light Therapy Device has incorporated protective eye-shield which blocks light energy from LEDs.

    AI/ML Overview

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