Michael Barbella, Managing Editor04.25.23
Apyx Medical Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance to use its Renuvion APR Handpiece for delivering radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed, including subcutaneous tissue.
“We are pleased to receive this 510(k) clearance with specific indication language related to the use of the Renuvion APR Handpiece for the contraction of soft tissues, including subcutaneous tissue, where needed,” Apyx Medical President/CEO Charlie Goodwin said. “The receipt of this 510(k) clearance further demonstrates the safety and effectiveness of Renuvion, and our commitment to working with the FDA to secure specific clinical indications related to its use. To this end, our 510(k) submission to obtain an additional specific indication for the use of the Renuvion APR Handpiece for the contraction of subcutaneous soft tissues where needed following liposuction remains under review by the FDA, and we look forward to receiving the agency’s decision.”
Apyx Medical Corporation is an advanced energy technology company that developed and commercialized Helium Plasma Technology products marketed and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market. Renuvion and J-Plasma offer surgeons the ability to provide controlled heat to tissue to achieve their desired results. The company also leverages its deep expertise and decades of experience in waveforms through OEM agreements with other medical device manufacturers.
“We are pleased to receive this 510(k) clearance with specific indication language related to the use of the Renuvion APR Handpiece for the contraction of soft tissues, including subcutaneous tissue, where needed,” Apyx Medical President/CEO Charlie Goodwin said. “The receipt of this 510(k) clearance further demonstrates the safety and effectiveness of Renuvion, and our commitment to working with the FDA to secure specific clinical indications related to its use. To this end, our 510(k) submission to obtain an additional specific indication for the use of the Renuvion APR Handpiece for the contraction of subcutaneous soft tissues where needed following liposuction remains under review by the FDA, and we look forward to receiving the agency’s decision.”
Apyx Medical Corporation is an advanced energy technology company that developed and commercialized Helium Plasma Technology products marketed and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market. Renuvion and J-Plasma offer surgeons the ability to provide controlled heat to tissue to achieve their desired results. The company also leverages its deep expertise and decades of experience in waveforms through OEM agreements with other medical device manufacturers.