Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K232763
    Device Name
    Electrode Handpieces (VCT, RFTV, BMDT series)
    Date Cleared
    2023-10-04

    (26 days)

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

    RF Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Electrodes Handpieces (VCT, RFTV, BMDT) are indicated for coagulation and ablation of tissue when used in conjunction with Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).
    Device Description
    Electrodes Handpieces (VCT, RFTV, BMDT) are sterile, single-use electrosurgical electordes intended to be use in conjunction with with compatible radio frequency generator, mainly Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277). Electrodes Handpieces (VCT, RFTV, BMDT) consist of electrode tip, insulation part, handle. Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (VCT, RFTV, BMDT), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.
    Ask a Question

    Ask a specific question about this device

    K Number
    K221277
    Device Name
    Mygen M-3004 RF Generator M-3004
    Date Cleared
    2022-09-02

    (122 days)

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

    RF Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mygen M-3004 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
    Device Description
    Mygen M-3004 RF System consists of a microprocessor based RF generator, a cooling pump and tubing, electrodes, and ground pads. The generator, pump and electrodes are designed to produce local tissue heating at the tip of the electrodes causing the coagulation (ablation) of the tissue. Mygen M-3004 RF System generator is capable of delivering up to 200 waits (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the RF energy. The generator includes manual and impedance control and displays/monitors impedance, current, power and temperature. The radiofrequency (RF) energy, which is delivered to an electrode, makes frictional heat for coagulation and ablation on diseased tissue by ionic agitation. The patient can receive safe therapy as leakage current is extremely low. Mygen M-3004 continually measures and displays RF output power, tissue impedance, and elapsed time of RF delivery. Tissue temperature is measured by the thermocouple embedded in the electrode tip and is displayed on the touch screen. This equipment automatically adjusts the output to maximize the delivery of high-frequency energy and displays the measured temperature from the treatment site during high-frequency emission. Mygen M-3004 automatically adjusts the output to optimize radiofrequency output and displays the measured temperature from the treatment area while delivering radiofrequency energy.
    Ask a Question

    Ask a specific question about this device

    K Number
    K193355
    Device Name
    Electrodes Handpieces for Mygen V-1000 RF System
    Date Cleared
    2020-08-03

    (243 days)

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

    RF Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.
    Device Description
    Electrodes Handpieces (BT, JET) are sterile, single-use electrosurgical electordes intended to be use in conjunction with Mygen V-1000 RF generator (K180999). Electrodes Handpieces (BT, JET) consist of electrode tip, insulation part, handle. Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (BT, JET), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.
    Ask a Question

    Ask a specific question about this device

    K Number
    K180999
    Device Name
    Mygen V-1000 RF System
    Date Cleared
    2018-12-11

    (239 days)

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

    RF Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mygen V-1000 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
    Device Description
    Electrosurgical, cutting & coagulation device & accessories
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1