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510(k) Data Aggregation

    K Number
    K252603

    Validate with FDA (Live)

    Device Name
    HIGHERDOSE Body Sculptor (Model: GS-03)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Date Cleared
    2026-01-28

    (163 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K223893,K250532,K242789
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HIGHERDOSE BODY SCULPTOR (Model: GS-03) is an over-the-counter device that is intended to improve the appearance of wrinkles.

    Device Description

    The HIGHERDOSE Body Sculptor (Model: GS-03) is a home-use light-emitting diode phototherapy device with two proven wavelengths of light 650nm Red light and 850nm Near infrared red light, both of these lights are known to reducing the wrinkle.

    The main device is made of black plastic (ABS+PC) and silicone button cup, and contain light emitting diode (LED) which will emit red light and infrared light. The device is a handheld device.

    The device contains a rechargeable Lithium battery, which can be charged by charging disk. The HIGHERDOSE Body Sculptor cannot be operated while charging.

    Press and hold the power button to turn the product on/off. Press the power button briefly to turn the LED light therapy on/off.

    The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

    AI/ML Overview

    N/A

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