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    K Number
    K251649
    Device Name
    Sunny Plus (Sunny)
    Manufacturer
    ShenB Co., Ltd
    Date Cleared
    2025-09-18

    (112 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K173093
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Low Frequency Electric Stimulator: This Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.

    Device Description

    The Sunny Plus device is a Low Frequency Electric Stimulator that conveys current to the human body through a non-invasive electrode with a frequency of 10Hz. It is composed of the main body, handpiece with electrode tip, and foot switch. The device is operated through a graphic user interface on an LCD screen and is intended to be operated by medical professionals.

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