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510(k) Data Aggregation

    K Number
    K252553

    Validate with FDA (Live)

    Device Name
    Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
    Manufacturer
    Shenzhen Jianchao Intelligent Technology Co., LTD
    Date Cleared
    2025-10-09

    (57 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K233010,K244004
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Facial & Body Beauty Device is a hand-held device for over-the-counter aesthetic purposes.
    The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.

    Device Description

    Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging. To use the device, user should place the electrode head on the face and body. The device will automatically shut down after treatment time is over.

    AI/ML Overview

    N/A

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