Apyx Medical Corporation Submits 510(k) Premarket Notification to the U.S. Food and Drug Administration for the AYON Body Contouring System™

Core Viewpoint - Apyx Medical Corporation has submitted a 510(k) premarket notification to the FDA for its AYON Body Contouring System, which aims to revolutionize body contouring procedures by providing an all-in-one solution for surgeons [1][2][4]. Product Development - The AYON Body Contouring System is designed to be versatile and innovative, integrating multiple advanced modalities to perform functions such as fat removal, tissue contraction, and aesthetic enhancement [2]. - The company plans to expand the indications for AYON with an additional 510(k) submission later in the year to include power-assisted liposuction [3]. Company Positioning - The AYON Body Contouring System is expected to differentiate Apyx Medical in the aesthetic surgical market, positioning the company as a premier provider in this field [4]. - The announcement of the submission was made approximately 90 days earlier than anticipated, highlighting the efficiency of the company's research, development, quality, and regulatory teams [4]. Company Background - Apyx Medical Corporation specializes in advanced energy technology, particularly its Helium Plasma Platform Technology products marketed as Renuvion and J-Plasma, which provide controlled heat to tissue for surgical procedures [5]. - The effectiveness of Renuvion and J-Plasma is supported by over 90 clinical documents, showcasing the company's commitment to innovation and clinical validation [5].