Bovie Medical (NYSE:BVX) said today it submitted a 510(k) premarket notification to the FDA seeking expanded clearance for its J-Plasma and Renuvion technology.
The Clearwater, Fla.-based company, which is looking to rebrand under the new moniker Apyx Medical Corporation beginning next year, said it is looking to clear the system for use in dermal resurfacing procedures.
The J-Plasma device is a plasma-based cutter and coagulator that uses helium ionization to produce a focused beam of ionized gas over a blade, used for cutting or coagulating during surgeries, Bovie Medical said.
“We are pleased to announce this 510(K) submission requesting clearance for a new clinical indication to market and sell our Renuvion cosmetic technology for dermal resurfacing procedures, which represents another important step towards our strategic objective to expand Renuvion’s clinical indications for use in the cosmetic surgery market. Our submission is supported by data from our multi-center, single arm, evaluator-blind prospective study evaluating the safety and efficacy of our Renuvion technology for the reduction of facial wrinkles and rhytides, which was conducted at three investigational centers and consisted of 55 patients. We were very pleased with the clinical results of this study and we are optimistic in receiving regulatory clearance for this differentiated technology in 2019,”
In August, Bovie dealt its core business, including the Bovie brand, to Symmetry Surgical for $97 million. The all-cash sale augured a pivot for Bovie toward the cosmetic surgery market with its J-Plasma and Renuvion brands.
