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news.Bovie Medical, a manufacturer and marketer of electrosurgical products, has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance for its Icon GS electrosurgical generator and handpiece or J-Plasma system.
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The technology utilizes a gas ionization process producing a stable thin focused beam of ionized gas that can be controlled in a range of temperatures and intensities, providing the surgeon greater precision, minimal invasiveness and an absence of conductive currents during surgery, said Bovie Medical.
Recent engineering improvements include increases in power and efficiency and component miniaturization, making manufacturing easier and more efficient, the company added.
Andrew Makrides, president and CEO of Bovie Medical, said: “Since the 2007 acquisition giving Bovie total ownership of Icon GS electrosurgical generator and handpiece (J-Plasma), the company has changed and improved the device. By incorporating Bovie’s Icon technology as a platform for J-Plasma, we have enhanced the flexibility of the product as well as its potential applications.”