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    K Number
    K121977
    Device Name
    PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
    Manufacturer
    PLASMA SURGICAL LIMITED
    Date Cleared
    2012-11-20

    (138 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLASMA SURGICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PlasmaJet® system is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery.
    Device Description
    The PlasmaJet® system comprises: a) PlasmaJet® console (Version 3-Plus), b) PlasmaJet® service module, c) PlasmaJet® open surgery handpieces, and d) PlasmaJet® laparoscopic surgery handpieces. It is a neutral plasma surgery system. The latest version of the PlasmaJet® console (Version 3-Plus) features rapidly pulsed plasma in a so-called "Ultra" mode that provides optimal cutting and coagulation capability.
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