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.
The Company is hosting key opinion leader event on Tuesday, October 14, 2025, at 12:00 PM ET that will feature Paul Vanek, Jr., MD. FACS, Founder, President and CEO of Mentor Plastic Surgery & MedSpa, who will join Apyx’s management to discuss the commercial launch of the new AYON Body Contouring System™. To register for the event .
Investor Relations Contact:
Jeremy Feffer, Managing Director LifeSci Advisors
OP: 212-915-2568
About Apyx Medical Corporation:
Apyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Platform Technology products marketed and sold as Renuvion and the AYON Body Contouring SystemTM in the cosmetic surgery market and J-Plasma® in the hospital surgical market. Renuvion and J-Plasma offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results. The effectiveness of Renuvion and J-Plasma are supported by more than 90 clinical documents. The AYON Body Contouring SystemTM is an FDA-cleared, 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. The Company also leverages its deep expertise and decades of experience in unique waveforms through OEM agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at .
Cautionary Statement on Forward-Looking Statements:
Certain matters discussed in this release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.
All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but not limited to, projections of net revenue, margins, expenses, net earnings, net earnings per share, or other financial items; projections or assumptions concerning the possible receipt by the Company of any regulatory approvals from any government agency or instrumentality including but not limited to the U.S. Food and Drug Administration (the “FDA”), supply chain disruptions, component shortages, manufacturing disruptions or logistics challenges; or macroeconomic or geopolitical matters and the impact of those matters on the Company’s financial performance.
Forward-looking statements and information are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that may cause the Company’s actual results to differ materially and that could impact the Company and the statements contained in this release include but are not limited to risks, uncertainties and assumptions relating to the regulatory environment in which the Company is subject to, including the Company’s ability to gain requisite approvals for its products from the FDA and other governmental and regulatory bodies, both domestically and internationally; sudden or extreme volatility in commodity prices and availability, including supply chain disruptions; changes in general economic, business or demographic conditions or trends; changes in and effects of the geopolitical environment; liabilities and costs which the Company may incur from pending or threatened litigations, claims, disputes or investigations; and other risks that are described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and the Company’s other filings with the Securities and Exchange Commission. For forward-looking statements in this release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.
