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510(k) Data Aggregation

    K Number
    K253073
    Device Name
    LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)
    Manufacturer
    Sunglor Technology Co., Ltd.
    Date Cleared
    2025-11-19

    (57 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K241857,K242382,K223544
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Led Light Therapy Device (Model:SG-FSM) is an Over-the-Counter medical device intended for treatment of wrinkles in the face and decolletage area.

    • Red light: Treatment of wrinkles.
    • Red+Infrared Light: Treatment of wrinkles.
    • Amber light: Treatment of wrinkles.
    • Amber+Infrared Light: Treatment of wrinkles.

    The Led Light Therapy Device (Model:SG-NK) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area.

    • Red light: Treatment of wrinkles.
    • Red+Infrared Light: Treatment of wrinkles.
    • Amber light: Treatment of wrinkles.
    • Amber+Infrared Light: Treatment of wrinkles.

    The Led Light Therapy Device (Model:SG-CT) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area.

    • Red light: Treatment of wrinkles.
    • Red+Infrared light: Treatment of wrinkles.
    • Infrared light: Provide topical heating for the purpose of elevating tissue temperature, and to temporarily increase local blood circulation.
    Device Description

    The Led Light Therapy Device is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles.

    LED Light Therapy Device(Model:SG-FSM) is consisting of Flexible silicone panel (LED mask and upper chest), controller, silicone eye protector, USB charging cable and straps.

    LED Light Therapy Device(Model:SG-NK, SG-CT) is consisting of Flexible silicone panel (upper chest), controller, USB charging cable and straps.

    The LED Light Therapy Device(Model:SG-FSM) have 3 types of light, which include Red light (wavelength 630nm), Infrared light (wavelength 850nm for LED mask, wavelength 830nm for upper chest) and Amber light (wavelength 605nm).

    The LED Light Therapy Device(model:SG-NK) have 3 types of light, which include Red light (wavelength 630nm), Infrared light (wavelength 830nm) and Amber light (wavelength 605nm).

    The LED Light Therapy Device (Model:SG-CT) have 2 types of light, which include Red light (wavelength 630nm) and Infrared light (wavelength 830nm).

    The LED Light Therapy Device is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.

    The device operates on an internal lithium rechargeable battery. The rechargeable battery can be charged from the external charging adapter through the provided USB Charging Cable. The USB charging cable is only used for charging, and the device cannot be used while charging.

    AI/ML Overview

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