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510(k) Data Aggregation
K Number
K232763Device Name
Electrode Handpieces (VCT, RFTV, BMDT series)
Manufacturer
Date Cleared
2023-10-04
(26 days)
Product Code
Regulation Number
878.4400Why 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.
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K Number
K221277Device Name
Mygen M-3004 RF Generator M-3004
Manufacturer
Date Cleared
2022-09-02
(122 days)
Product Code
Regulation Number
878.4400Why 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.
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K Number
K193355Device Name
Electrodes Handpieces for Mygen V-1000 RF System
Manufacturer
Date Cleared
2020-08-03
(243 days)
Regulation Number
878.4400Why 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.
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K Number
K180999Device Name
Mygen V-1000 RF System
Manufacturer
Date Cleared
2018-12-11
(239 days)
Product Code
Regulation Number
878.4400Why 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
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