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

    Soniquence RF Generator and Soniquence Electrodes

    K Number: K183611 · Decision May 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    6
    Review Days
    147

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    Basic Information

    Device Name
    Soniquence RF Generator and Soniquence Electrodes
    K Number
    K183611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Soniquence, LLC
    Date Received
    December 26, 2018
    Decision Date
    May 22, 2019
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Soniquence, LLC

    K Number Device Name
    K254220 Reusable 3 Button Fingerswitch Wand
    K212222 Soniquence Reusable 3 Button Fingerswitch Wand
    K220071 Soniquence Reusable Neutral Plate
    K211946 Soniquence Reusable Bipolar Cable
    K190336 Soniquence Bipolar Electrodes