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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇿 Czechia

    JETT PLASMA Medical II

    K Number: K213247 · Decision Mar 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    530

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    Basic Information

    Device Name
    JETT PLASMA Medical II
    K Number
    K213247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Compex, Spol, S.R.O.
    Date Received
    September 30, 2021
    Decision Date
    March 14, 2023
    Product Code
    QVJ
    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
    QVJ Low Power Electrosurgical Devices For Skin Lesion Destruction

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    Other Clearances by Compex, Spol, S.R.O.

    K Number Device Name
    K240311 JETT Medical II