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

    Trinity Plus Wrinkle Reducer

    K Number: K212947 · Decision Apr 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    7
    Review Days
    199

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    Basic Information

    Device Name
    Trinity Plus Wrinkle Reducer
    K Number
    K212947
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carol Cole Company Dba Nuface
    Date Received
    September 15, 2021
    Decision Date
    April 2, 2022
    Product Code
    OHS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OHS Light Based Over The Counter Wrinkle Reduction

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    Other Clearances by Carol Cole Company Dba Nuface

    K Number Device Name
    K201906 Trinity ELE Plus and Trinity ELE Plus Pro
    K201782 NuFace Trinity Plus Device
    K191672 NuFACE Mini Device
    K182424 NuFACE FIX Skin Toning Device
    K181008 NuFACE Trinity
    K171588 NuBODY Skin Toning Device