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

    ENEO TOTALE (Model: ENEOT947)

    K Number: K213841 · Decision Jan 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    6
    Review Days
    28

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    Basic Information

    Device Name
    ENEO TOTALE (Model: ENEOT947)
    K Number
    K213841
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Premier North America, Inc.
    Date Received
    December 9, 2021
    Decision Date
    January 6, 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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