Apyx Medical Corporation has achieved a significant regulatory milestone with the U.S. Food and Drug Administration's 510(k) clearance for its AYON Body Contouring System, positioning the device as the first FDA-cleared all-in-one platform for aesthetic surgical suites. The company plans to initiate commercial launch with key opinion leader surgeons in critical geographies during the second half of 2025.
Revolutionary All-in-One Platform Design
The AYON Body Contouring System represents a groundbreaking approach to aesthetic surgery, seamlessly integrating fat removal, closed loop contouring, tissue contraction, and electrosurgical capabilities into a single platform. The surgeon-designed system incorporates advanced features including LIFT Technology for real-time adjustments and Apyx Medical's proprietary Renuvion technology for enhanced tissue contraction.
"Receiving FDA clearance for the AYON Body Contouring System, which includes our proprietary Renuvion technology for the treatment of loose and lax skin, marks a major step forward in our mission to empower surgeons with transformative tools," said Charlie Goodwin, President and CEO of Apyx Medical Corporation. "By uniting multiple technologies into one powerful platform, AYON is designed to streamline procedures, elevate surgical precision, and ultimately deliver better outcomes for patients."
Comprehensive Treatment Capabilities
The initial 510(k) clearance encompasses a wide variety of aesthetic treatments, including Renuvion for addressing loose and lax skin, ultrasound-assisted liposuction, and electrocoagulation to support procedures requiring removal of excess tissue. The company has outlined plans to expand the cleared indications for AYON to include power liposuction through an additional 510(k) submission later this year.
Market Timing and GLP-1 Drug Impact
The FDA clearance comes at a strategically important time for the aesthetics market, which is anticipating rapid growth in body contouring procedures. Goodwin highlighted the significant market opportunity, noting that "more than 15 million patients currently using GLP-1 drugs achieve rapid weight loss and seek solutions for addressing their loose and lax skin and reshaping their new bodies. AYON provides surgeons with all the necessary solutions in one device for meeting the needs of these patients."
Technology Foundation and Clinical Evidence
Apyx Medical Corporation leverages its expertise in advanced energy technology, particularly its Helium Plasma Platform Technology. The company's Renuvion and J-Plasma technologies offer surgeons controlled heat delivery to tissue, with effectiveness supported by more than 90 clinical documents. The AYON system builds upon this foundation while expanding capabilities into a comprehensive body contouring solution.
The company's approach emphasizes evidence-based design and consistent, reliable performance, positioning AYON to deliver what the company describes as "an unmatched return on investment" for surgical practices. As the first FDA-cleared system of its kind, AYON represents a significant advancement in aesthetic surgery technology integration.
