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

    Plasma Pen (Plasma MD); Plasma Pen (Plasma +)

    K Number: K223440 · Decision Mar 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    108

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    Basic Information

    Device Name
    Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
    K Number
    K223440
    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
    Plasma Concepts
    Date Received
    November 14, 2022
    Decision Date
    March 2, 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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