Bovie Medical Corp. received U.S. Food and Drug Administration (FDA) 510(k) clearance for six new hand-piece configurations that expand its the company's J-Plasma pistol-grip portfolio.
The Clearwater, Fla.-based firm manufactures medical devices and supplies.
The pistol grip hand piece will now be available with instrument lengths of 15 centimeters (cm), 33 cm and 45 cm, in addition to the existing length of 27 cm. Also, each of the the new length hand pieces will be available with a new needle configuration, as well as the standard blade configuration. The new configurations have received FDA clearance and will be available beginning this month.
“In commercializing J-Plasma, we have implemented a voice of customer initiative that resulted in new designs to respond to specific surgical needs,” said Robert L. Gershon, CEO. “The new lengths of our pistol grip hand pieces offer surgeons greater access and increases the opportunity for adoption across multiple specialties, while the new needle tip configuration provides even more precision resulting in less collateral damage to unintended tissue.”
J-Plasma, is a patented new plasma-based surgical product for cutting and coagulation. The device uses a helium ionization process to produce a stable, focused beam of ionized gas that, according to the company, "provides surgeons with greater precision, minimal invasiveness and an absence of conductive currents through the patient during surgery."
Bovie Medical also makes a range of electrosurgical products and technologies, marketed through private labels and the company’s own brands (Bovie, Aaron, IDS and ICON). The company also provides contract manufacturing services for other medical device manufacturers.