BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Microcurrent Facial Device (CEC101, EE0101, EEI101)

    K Number: K244004 · Decision Jul 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    77
    Applicant Total
    2
    Review Days
    196

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    Basic Information

    Device Name
    Microcurrent Facial Device (CEC101, EE0101, EEI101)
    K Number
    K244004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Dachi Communication Co., Ltd.
    Date Received
    December 26, 2024
    Decision Date
    July 10, 2025
    Product Code
    NFO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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    Other Clearances by Shenzhen Dachi Communication Co., Ltd.

    K Number Device Name
    K252642 Microcurrent Facial Device (CEC101, EEI101)