BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Mjolnir Pro. (Multi–electrode plasma)

    K Number: K233760 · Decision Feb 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    88

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    Basic Information

    Device Name
    Mjolnir Pro. (Multi–electrode plasma)
    K Number
    K233760
    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
    Shenzhen Leaflife Technology Co., Ltd.
    Date Received
    November 24, 2023
    Decision Date
    February 20, 2024
    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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