Apyx Medical Corp Submits 510(k) Premarket Notification To The U.S. FDA ForTthe AYON Body Contouring System
Benzinga Newsdesk 1 year ago
BiotechNewsFDAGeneral
Apyx® Medical Corporation (NASDAQ:APYX) ("Apyx Medical"; the "Company"), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, is pleased to announce it
Apyx® Medical Corporation (NASDAQ:APYX) ("Apyx Medical"; the "Company"), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, is pleased to announce it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (the "FDA") for the AYON Body Contouring System.
The AYON Body Contouring System was developed with a focus on versatility and innovation. AYON has been designed to be the only device a surgeon needs for comprehensive body contouring solutions. This all-in-one system integrates advanced modalities to perform multiple functions seamlessly, removing unwanted fat, enhancing tissue contraction and addressing the full range of patient needs from contouring to aesthetic enhancement. The initial submission for AYON includes the following:
- Infiltration
- Dual aspiration to facilitate simultaneous users
- Ultrasound-assisted liposuction
- Electrocoagulation to support procedures requiring removal of excess tissue
- Volume enhancement capabilities
- Renuvion treatment to address loose and lax skin
Later this year, the Company plans to expand the indications with an additional 510(k) submission for AYON to include power assisted liposuction.