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510(k) Data Aggregation

    K Number
    K213247
    Device Name
    JETT PLASMA Medical II
    Manufacturer
    Compex, Spol. s.r.o
    Date Cleared
    2023-03-14

    (530 days)

    Product Code
    QVJ
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    JETT PLASMA Medical II

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    JETT PLASMA Medical II is used in the removal and destruction of skin lesions and coagulation of tissue.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

    The document is an FDA 510(k) clearance letter for the "JETT PLASMA Medical II" device. It primarily discusses:

    • The FDA's determination of substantial equivalence to a predicate device.
    • Regulatory requirements the manufacturer must follow.
    • The indications for use of the device: "removal and destruction of skin lesions and coagulation of tissue."

    It does not include:

    • A table of acceptance criteria or reported device performance metrics.
    • Details on specific studies, sample sizes, data provenance, or ground truth establishment.
    • Information about expert adjudication, MRMC studies, or standalone algorithm performance.

    To provide the information you've requested, I would need a different type of document, such as a clinical study report, a performance validation report, or a summary of safety and effectiveness from the 510(k) submission itself (which often contains more technical details than the clearance letter).

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