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510(k) Data Aggregation

    K Number
    K240504
    Device Name
    PLASMA EDGE System
    Manufacturer
    Lamidey Noury Medical
    Date Cleared
    2024-06-12

    (112 days)

    Product Code
    FAS, FDC, GEI
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lamidey Noury Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in: - Transurethral resection of prostate (TURP) for benign prostatic hypertrophy - Transurethral incision of the prostate (TUIP) or bladder neck - Transurethral resection of bladder tumors (TURBT) - Cystodiathermy - Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. (MVVS models only)
    Device Description
    The Plasma Edge system is a manual surgical device, consisting of a single-use electrode, an active and passive working element reusable and an adaptor or only socket with memory (fixed cable) to connect them to an HF generator compatible. The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip. It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
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    K Number
    K222542
    Device Name
    MCB UNIT Model: V10GMCBUS
    Manufacturer
    Lamidey Noury Medical
    Date Cleared
    2022-09-21

    (30 days)

    Product Code
    KNS, GEI
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lamidey Noury Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical unit « MCB » is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in endoscopic urological surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
    Device Description
    MCB is a reusable, non-sterile electrosurgical bipolar generator with cutting and coagulation modes. The maximum output power is 500 W. The front panel GUI (graphical user interface) features soft keys and digital displays for: • the connection status of accessories connected to the electrosurgical generator. • the current settings of the chosen output mode (Cut/ Coag), and possibility to adjust it • Sound Level adjustment and LEDs (Green for Sound and Yellow/Blue for output activation) • Electrode shortcut Alarm reset At switch on, Serial Number and Software Version are displayed
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