Apyx Medical Corporation Submits FDA 510(k) for Device Label Expansion of AYON Body Contouring System™ for Power Liposuction
Apyx Medical (NASDAQ: APYX) announced on October 13, 2025 that it submitted a new FDA 510(k) premarket notification to expand the label of the AYON Body Contouring System to include power liposuction.
The company began a nationwide commercial launch of AYON in September 2025 and said that, if cleared, the power liposuction function could be activated in systems already installed at U.S. surgical centers.
A virtual key opinion leader event on October 14, 2025 will discuss the commercial launch.
Apyx Medical (NASDAQ: APYX) ha annunciato il 13 ottobre 2025 di aver inviato una nuova notifica premarket FDA 510(k) per espandere l'etichetta del AYON Body Contouring System per includere la liposuzione ad alta potenza.
L'azienda ha avviato un lancio commerciale nazionale di AYON nel settembre 2025 e ha dichiarato che, se autorizzata, la funzione di liposuzione ad alta potenza potrebbe essere attivata sui sistemi già installati presso i centri chirurgici statunitensi.
Un evento virtuale con un opinion leader di riferimento previsto per 14 ottobre 2025 discuterà del lancio commerciale.
Apyx Medical (NASDAQ: APYX) anunció el 13 de octubre de 2025 que presentó una nueva notificación previa al mercado FDA 510(k) para ampliar la etiqueta del AYON Body Contouring System para incluir la liposucción de alta potencia.
La empresa inició un lanzamiento comercial nacional de AYON en septiembre de 2025 y dijo que, de ser aprobada, la función de liposucción de alta potencia podría activarse en los sistemas ya instalados en los centros quirúrgicos de EE. UU.
Un evento virtual con un líder de opinión clave programado para el 14 de octubre de 2025 discutirá el lanzamiento comercial.
Apyx Medical (NASDAQ: APYX)는 2025년 10월 13일에 FDA 510(k) 프리마켓 알림을 제출하여 AYON 바디 컨투어링 시스템의 라벨에 강력 지방흡입을 포함하도록 확장했다고 발표했습니다.
이 회사는 2025년 9월에 AYON의 전국 상용 출시를 시작했으며, 허가가 나면 미국 외래 센터에 이미 설치된 시스템에서 강력 지방흡입 기능을 활성화할 수 있다고 밝혔습니다.
가상 주요 의견 리더(KOL) 이벤트가 2025년 10월 14일에 열려 상용 출시를 논의할 예정입니다.
Apyx Medical (NASDAQ: APYX) a annoncé le 13 octobre 2025 avoir soumis une nouvelle notification pré-commercialisation FDA 510(k) afin d’étendre l’étiquette du AYON Body Contouring System pour inclure la liposuccion puissante.
L’entreprise a commencé un lancement commercial national d’AYON en septembre 2025 et a déclaré que, si approuvée, la fonction de liposuccion puissante pourrait être activée sur les systèmes déjà installés dans les centres chirurgicaux américains.
Un événement virtuel avec un leader d’opinion clé prévu le 14 octobre 2025 discutera du lancement commercial.
Apyx Medical (NASDAQ: APYX) hat am 13. Oktober 2025 mitgeteilt, dass es eine neue FDA 510(k) Premarket-Mitteilung eingereicht hat, um das Label des AYON Body Contouring System zu erweitern und Power-Liposuktion aufzunehmen.
Das Unternehmen begann im September 2025 mit der landesweiten Markteinführung von AYON und erklärte, dass, falls freigegeben, die Funktion der Power-Liposuktion bei bereits am US-Standorten installierten Systemen aktiviert werden könnte.
Eine virtuelle Veranstaltung mit einem führenden Meinungsbildner (KOL) am 14. Oktober 2025 wird den Markteinführungsprozess diskutieren.
Apyx Medical (NASDAQ: APYX) أعلنت في 13 أكتوبر 2025 أنها قدمت إشعاراً مسبقاً للسوق FDA 510(k) جديداً لتوسيع تسمية AYON Body Contouring System ليشمل شفط الدهون بقوة.
بدأت الشركة بإطلاق تجاري وطني لـ AYON في سبتمبر 2025 وأكدت أنه، إذا تمت الموافقة، يمكن تفعيل وظيفة شفط الدهون بقوة على الأنظمة التي تم تركيبها بالفعل في مراكز الجراحة الأمريكية.
سيعقد حدث افتراضي لقائد رأي رئيسي في 14 أكتوبر 2025 لمناقشة الإطلاق التجاري.
Apyx Medical (NASDAQ: APYX) 于2025年10月13日宣布提交了新的FDA 510(k)上市前通知，以扩展AYON Body Contouring System的标签，纳入强力吸脂功能。
公司在2025年9月开始 nationwide 的 AYON 商业推广，并表示如果获得批准，已经在美国手术中心安装的系统中的强力吸脂功能可以被激活。
原定于2025年10月14日举行的虚拟关键意见领袖（KOL）活动将讨论商业推广。
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Insights
Apyx submitted a 510(k) to add power liposuction to AYON, advancing its goal of an all‑in‑one contouring platform.
Apyx Medical filed a new 510(k) premarket notification on
The business benefit, if clearance arrives, is that AYON could operate as a single platform covering fat removal and tissue contraction, simplifying workflow for surgeons and increasing the system's functional scope. The primary dependency is clear: this expansion requires FDA clearance before the new feature can be activated in installed systems; no clearance or timing claims are made in the release.
Watch for the FDA 510(k) clearance decision and any subsequent company communications about activation of power liposuction functionality in installed units. Also track feedback from the October
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 click here.
Investor Relations Contact:
Jeremy Feffer, Managing Director LifeSci Advisors
OP: 212-915-2568
jfeffer@lifesciadvisors.com
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 www.ApyxMedical.com.
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.
FAQ
What did Apyx (APYX) file with the FDA on October 13, 2025?
How could FDA clearance for power liposuction affect AYON systems already installed?
When did Apyx begin its nationwide commercial launch of AYON?
What is the significance of adding power liposuction to AYON for surgeons?
When is Apyx hosting the virtual key opinion leader event about AYON?
Does the October 13, 2025 announcement state that FDA clearance has been granted?
