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

    Venus VivaTM

    K Number: K191065 · Decision Apr 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    11
    Review Days
    345

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    Basic Information

    Device Name
    Venus VivaTM
    K Number
    K191065
    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
    Venus Concept USA, Inc.
    Date Received
    April 22, 2019
    Decision Date
    April 1, 2020
    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 Venus Concept USA, Inc.

    K Number Device Name
    K221011 AI.ME System
    K220592 Venus BlissMAX
    K213308 Venus BlissMAX
    K211461 Family of Venus RF Systems - Venus Freedom
    K201164 Venus Viva MD Device
    K200786 Venus Epileve
    K191528 Venus Legacy Pro Device
    K190743 Venus Bliss
    K182094 Family of Venus RF Systems - Heal
    K142910 Legacy BX
    Search all 11 clearances from Venus Concept USA, Inc. →