BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NuFACE Mini Plus

    K Number: K201680 · Decision Feb 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    77
    Applicant Total
    1
    Review Days
    242

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    Basic Information

    Device Name
    NuFACE Mini Plus
    K Number
    K201680
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carole Cole Company
    Date Received
    June 22, 2020
    Decision Date
    February 19, 2021
    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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