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

    NUFACE PLUS

    K Number: K103472 · Decision Nov 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    348

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    Basic Information

    Device Name
    NUFACE PLUS
    K Number
    K103472
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carol Cole Company
    Date Received
    November 24, 2010
    Decision Date
    November 7, 2011
    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 Carol Cole Company

    K Number Device Name
    K161654 NuFACE Gel Primer
    K133823 NUFACE MINI DEVICE
    K131251 TRINITY ELE
    K120560 TRINITY WRINKLE REMOVER
    K072260 NUFACE, MODEL NU-4003