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

    Trinity ELE Plus and Trinity ELE Plus Pro

    K Number: K201906 · Decision Feb 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    77
    Applicant Total
    7
    Review Days
    230

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    Basic Information

    Device Name
    Trinity ELE Plus and Trinity ELE Plus Pro
    K Number
    K201906
    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
    July 9, 2020
    Decision Date
    February 24, 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
    K201782 NuFace Trinity Plus Device
    K191672 NuFACE Mini Device
    K182424 NuFACE FIX Skin Toning Device
    K181008 NuFACE Trinity
    K171588 NuBODY Skin Toning Device