Bovie Medical Corp., a manufacturer and marketer of electrosurgical products, today announced it has received 510k clearance from the U.S. Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature to be used for soft tissue coagulation during surgery.
The J-Plasma handpiece will be powered by Bovie's GS electrosurgical generator, which has also previously obtained 510k market clearance.
"This is a significant development toward Bovie becoming a leader in plasma surgery and achieving increased prominence in the electrosurgery marketplace," Bovie CEO Andrew Makrides stated in the press release.
Bovie recently received a United States patent for a "Method to generate a plasma stream for performing electrosurgery," adding to the company's J-Plasma™ patent portfolio of four patents and three additional patent applications pending.
Bovie said it will continue to explore and review added applications for J-Plasma, which include gynecology, dermatology, plastic surgery, infection control, use in robotics, and other surgical techniques. In addition, it plans to introduce J-Plasma at selected hospital beta sites and several university teaching facilities to prepare for market launch later this year.
The J-Plasma device passes an inert gas such as helium over a sharp conductive point that produces a luminous discharge beam. This sharp conductive point can also be in the form of a retractable surgical blade, which can be used for incisions and other cutting procedures; when retracted, the blade is used to form the J-Plasma beam for coagulation.
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