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

    NuFace Trinity Plus Device

    K Number: K201782 · Decision Jan 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    65
    Applicant Total
    7
    Review Days
    206

    Basic Information

    Device Name
    NuFace Trinity Plus Device
    K Number
    K201782
    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 dba NuFACE
    Date Received
    June 30, 2020
    Decision Date
    January 22, 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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    Other Clearances by Carol Cole Company dba NuFACE

    K Number Device Name
    K212947 Trinity Plus Wrinkle Reducer
    K201906 Trinity ELE Plus and Trinity ELE Plus Pro
    K191672 NuFACE Mini Device
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    K181008 NuFACE Trinity
    K171588 NuBODY Skin Toning Device