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

    NUFACE, MODEL NU-4003

    K Number: K072260 · Decision Nov 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    105

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    Basic Information

    Device Name
    NUFACE, MODEL NU-4003
    K Number
    K072260
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carol Cole Company
    Date Received
    August 14, 2007
    Decision Date
    November 27, 2007
    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
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    K133823 NUFACE MINI DEVICE
    K131251 TRINITY ELE
    K120560 TRINITY WRINKLE REMOVER
    K103472 NUFACE PLUS