Bovie Medical Corporation announced that the company has received 510(k) clearance from the Food and Drug Administration (FDA) to market its J-Plasma ICON GS electrosurgical generator and handpiece.
The technology utilizes a gas ionization process producing a stable thin focused beam of ionized helium gas that can be controlled in a wide range of temperatures and intensities, providing the surgeon greater precision, minimal invasiveness and an absence of conductive currents during surgery. Independent control of the beam power (heating) and helium flow rate (cooling) produces a highly localized effect with minimal collateral damage to the surrounding healthy tissue.
Management believes the J-Plasma technology has a wide variety of medical applications including dermatology, gynecology, hepatobiliary (liver), thoracic and general surgery. The Company is consulting with both domestic and international physicians and scientists experienced in the field of plasma medicine to accelerate the commercialization of the technology in the US and abroad.
Mr. David Uffer, vice president of advanced technologies and director of plasma sales and marketing will lead the Company’s efforts in developing the technology’s applications and commercialization.
Andrew Makrides, president of Bovie Medical stated, “Management remains very encouraged regarding the potential of the J-Plasma technology. The FDA clearance to market J-Plasma is a milestone in our continued evolution into a high-tech medical device company.”