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

    DEKA SMARTPERIO

    K Number: K213658 · Decision Mar 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    16
    Applicant Total
    27
    Review Days
    112

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    Basic Information

    Device Name
    DEKA SMARTPERIO
    K Number
    K213658
    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
    El.En Electronic Engineering Spa
    Date Received
    November 19, 2021
    Decision Date
    March 11, 2022
    Product Code
    NVK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NVK Laser, Dental, Soft Tissue

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