Medical device maker Bovie Medical has obtained 510(k) approval from the US Food and Drug Administration for its Bovie Ultimate generator.
The Bovie Ultimate is an electrosurgical generator, which can be used for delivery of RF energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures.
Bovie Medical CEO Robert Gershon said: "We are pleased to have received FDA approval for this leading edge product, which combines J-Plasma technology with the highest wattage operating room electrosurgical generator.
"We designed the Bovie Ultimate to provide medical practitioners with greater flexibility, including the ability to easily incorporate our J-Plasma product."
The generator’s pad-sensing system reduces the risk of patient burns, and it offers users monopolar, bipolar and plasma features, including one J-Plasma helium gas outlet, in a single generator.
The Bovie Ultimate will replace Bovie’s ICON GS plasma system and is expected to available from February 2015.
The company also produces J-Plasma, a patented plasma-based surgical product for cutting and coagulation. It uses a helium ionization process to produce a stable, focused beam of ionized gas that offers surgeons with better precision, minimal thermal spread and an absence of conductive currents through the patient during surgery.