Apyx Medical Corporation Submits FDA 510(k) for Device Label Expansion of AYON Body Contouring System for Power Liposuction

Initiated Nationwide Commercial Launch of AYON in September

The Company is Hosting a Virtual Key Opinion Leader Event to Discuss the Commercial Launch of AYON on October 14, 2025

CLEARWATER, Fla., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Apyx Medical Corporation (NASDAQ: APYX) (“Apyx Medical” or the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency platform technology marketed and sold as Renuvion and the AYON Body Contouring System, today announced the submission of a new 510(k) premarket notification to the U.S. Food and Drug Administration (the “FDA”) for the label expansion of the AYON Body Contouring System (“AYON”) to include power liposuction. Receiving market clearance for power liposuction would solidify AYON’s position as the first fully integrated body contouring system. As a result, surgeons would be able to address every aspect of contouring within one platform, streamlining workflow, and potentially enhancing outcomes, and positioning AYON as the new gold standard in surgical aesthetics.

“We are pleased to announce that our development strategy for AYON continues to advance at a rapid pace, including with the planned 510(k) submission to expand the AYON system to include power liposuction, which uses a reciprocating liposuction cannula to enhance the ability to remove fat with less manual effort for the surgeon. Upon receiving FDA clearance for power liposuction, we will be able to activate the new functionality in the AYON systems already installed at surgical centers across the U.S. through the ongoing commercial launch,” said Charlie Goodwin, President and Chief Executive Officer. “The feedback we have received from the early adopters of AYON for the currently cleared aesthetic procedures is overwhelmingly positive and we are excited to have recently expanded our commercial rollout to aesthetic surgeons across the U.S.”

AYON is a groundbreaking, surgeon-designed body contouring system that combines precision, versatility, and innovation in an all-in-one platform. It seamlessly integrates fat removal, closed loop contouring, tissue contraction, and electrosurgical capabilities, empowering surgeons to deliver the most comprehensive body contouring treatments for patients. With advanced features like LIFT Technology for real-time adjustments and Renuvion for enhanced tissue contraction, AYON sets a new standard in surgical care, streamlining procedures and maximizing patient outcomes. Backed by Apyx Medical’s expertise and evidence-based design, AYON delivers consistent, reliable performance and an unmatched return on investment. As the first of its kind, AYON is revolutionizing body contouring and shaping the future of aesthetic surgery.