Business Wire08.05.19
Apyx Medical Corporation, formerly Bovie Medical Corporation, a maker of medical devices and supplies and the developer of its Helium Plasma Technology, marketed and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market, received U.S. Food and Drug Administration (FDA) 510(k) clearance to market and sell its next-generation J-Plasma Precise Handpiece.
The company’s J-Plasma handpieces are indicated for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures. The original and next-generation of this J-Plasma Precise Handpiece is designed specifically for use in laparoscopic surgical procedures. Importantly, this next-generation handpiece incorporates the company’s Cool-Coag Technology, enhancing its utility by enabling surgeons to alternate between delivering precise, tissue-sparing J-Plasma energy, standard monopolar coagulation energy, and a non-contact ‘spray’ called Plasma Beam Coagulation, in the same handpiece. This next-generation handpiece is also 39% lighter than its predecessor for improved ergonomics.
“We are pleased to announce the receipt of 510(k) clearance for our next-generation J-Plasma Precise Handpiece. It is an important achievement for our company that was made possible by the efforts of both our Research and Development and Regulatory Affairs teams,” said Charlie Goodwin, CEO. “This next-generation J-Plasma Precise Handpiece was designed in response to demand from our surgeon customers outside the U.S. These customers requested a handpiece designed for use in laparoscopic surgery procedures that would enable them to deliver the precision of J-Plasma energy as well as the power of a monopolar coagulation waveform when needed for wider areas of coagulation. In response to this demand, we leveraged our research & development and manufacturing expertise to create this next-generation version of our J-Plasma Precise Handpiece, which features our Cool-Coag Technology and enhanced ergonomics. We look forward to beginning a limited launch of this product in Europe later this quarter.”
The company’s J-Plasma handpieces are indicated for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures. The original and next-generation of this J-Plasma Precise Handpiece is designed specifically for use in laparoscopic surgical procedures. Importantly, this next-generation handpiece incorporates the company’s Cool-Coag Technology, enhancing its utility by enabling surgeons to alternate between delivering precise, tissue-sparing J-Plasma energy, standard monopolar coagulation energy, and a non-contact ‘spray’ called Plasma Beam Coagulation, in the same handpiece. This next-generation handpiece is also 39% lighter than its predecessor for improved ergonomics.
“We are pleased to announce the receipt of 510(k) clearance for our next-generation J-Plasma Precise Handpiece. It is an important achievement for our company that was made possible by the efforts of both our Research and Development and Regulatory Affairs teams,” said Charlie Goodwin, CEO. “This next-generation J-Plasma Precise Handpiece was designed in response to demand from our surgeon customers outside the U.S. These customers requested a handpiece designed for use in laparoscopic surgery procedures that would enable them to deliver the precision of J-Plasma energy as well as the power of a monopolar coagulation waveform when needed for wider areas of coagulation. In response to this demand, we leveraged our research & development and manufacturing expertise to create this next-generation version of our J-Plasma Precise Handpiece, which features our Cool-Coag Technology and enhanced ergonomics. We look forward to beginning a limited launch of this product in Europe later this quarter.”