BEUDAMED
    Product Code: QVJ FDA class 2 21 CFR 878.4400

    Low Power Electrosurgical Devices For Skin Lesion Destruction

    General, Plastic Surgery

    The Low Power Electrosurgical Device for Skin Lesion Destruction, also known as a Plasma Pen Device, generates an electrical arc in ambient air between a probe tip and the skin to cause controlled tissue damage for the removal and destruction of skin lesions in general dermatological procedures. The device uses plasma energy to ablate superficial skin conditions without traditional blade or laser incision. Classified as FDA Class 2 under regulation 878.4400, it requires 510(k) clearance in the General and Plastic Surgery specialty. It is not an implant and not life-sustaining.

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    510(k)s
    4
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    4
    Years Active
    1

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    Basic Information

    Product Code
    QVJ
    Device Class
    FDA class 2
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For the removal and destruction of skin lesions in general dermatological procedures, also referred to as Plasma Pen Devices, which generates electrical arc in the ambient air between an electrical probe tip and the skin and cause intended tissue damage for the removal and destruction of skin lesions

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K233760 Mjolnir Pro. (Multi–electrode plasma)
    K220493 Plaxpot Multi Plasma
    K213247 JETT PLASMA Medical II
    K223440 Plasma Pen (Plasma MD); Plasma Pen (Plasma +)

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.