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510(k) Data Aggregation

    K Number
    K252786

    Validate with FDA (Live)

    Device Name
    Led Light Phototherapy Bed (Pro 450/ GY-680A)
    Manufacturer
    Shenzhen Suyzeko Limited.
    Date Cleared
    2025-12-01

    (90 days)

    Product Code
    OLI
    Regulation Number
    878.5400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K202955,K153399
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Led Light Phototherapy Bed is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

    Led Light Phototherapy Bed is indicated to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, and pain and stiffness associated with arthritis, for promoting relaxation of the muscle tissue, and to temporarily increase local blood circulation.

    Device Description

    LED phototherapy bed is a low-intensity LED light source (red and infrared LED) system that uses 630nm light to reduce the circumference of the hips, waist, and thighs for aesthetic benefits, and temporarily increases skin temperature using 630nm, 660nm, 855nm, and 940nm light.

    The device consists of two LED panels, a software control console for selecting and maintaining LED light applications, a power adapter, and cables connected to the energy source. The LED panels can be adjusted to roughly fit the external dimensions of the patient being treated. The device is powered by connecting it to an 220-240V AC, at4000VA, 50-60Hz power source.

    The equipment is controlled by professional operators. The operator control device includes additional safety measures, including an emergency stop button. If activated, the emergency stop will stop the program and shut down, delivering power to the treated person through the LED light.

    AI/ML Overview

    N/A

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