Apyx Medical Submits FDA 510(k) Application to Expand AYON Body Contouring System for Power Liposuction
核心洞察
Apyx Medical Corporation (搜索) has submitted a 510(k) premarket notification to the FDA seeking label expansion of its AYON Body Contouring System (搜索) to include power liposuction capabilities.
FDA clearance would position AYON as the first fully integrated body contouring system, allowing surgeons to address all aspects of body contouring within one platform.
The company initiated a nationwide commercial launch of AYON in September 2025, with early adopters providing overwhelmingly positive feedback on currently cleared aesthetic procedures.
Apyx Medical Corporation (搜索) announced the submission of a new 510(k) premarket notification to the U.S. Food and Drug Administration for label expansion of the AYON Body Contouring System (搜索) to include power liposuction. The regulatory filing represents a strategic advancement in the company's development of what could become the first fully integrated body contouring platform in surgical aesthetics.
Regulatory Strategy and Market Positioning
The 510(k) submission seeks to expand AYON's current FDA clearance to include power liposuction, which utilizes a reciprocating liposuction cannula to enhance fat removal with reduced manual effort for surgeons. According to Charlie Goodwin, President and Chief Executive Officer, receiving FDA clearance would "solidify AYON's position as the first fully integrated body contouring system" and enable surgeons to "address every aspect of contouring within one platform, streamlining workflow, and potentially enhancing outcomes."
The power liposuction functionality would be activated through software updates in AYON systems already installed at surgical centers across the United States, eliminating the need for hardware replacements during the ongoing commercial launch.
Technology Platform and Clinical Integration
AYON represents a surgeon-designed body contouring system that integrates multiple capabilities within a single platform. The system combines fat removal, closed loop contouring, tissue contraction, and electrosurgical capabilities. Advanced features include LIFT Technology for real-time adjustments and Renuvion (搜索) technology for enhanced tissue contraction.
The system builds upon Apyx Medical's helium plasma and radiofrequency platform technology, which is also marketed as Renuvion (搜索) in the cosmetic surgery market and J-Plasma (搜索) in the hospital surgical market. The effectiveness of these technologies is supported by more than 90 clinical documents, according to the company.
Commercial Launch and Market Reception
Apyx Medical initiated a nationwide commercial launch of AYON in September 2025, expanding access to aesthetic surgeons across the United States. Goodwin reported that "the feedback we have received from the early adopters of AYON for the currently cleared aesthetic procedures is overwhelmingly positive."
The company is hosting a virtual key opinion leader event on October 14, 2025, featuring Paul Vanek, Jr., MD, FACS, Founder, President and CEO of Mentor Plastic Surgery & MedSpa (搜索), to discuss the commercial launch of the AYON Body Contouring System (搜索).
Strategic Development Timeline
The 510(k) submission represents part of Apyx Medical's broader development strategy for AYON, which the company states "continues to advance at a rapid pace." The regulatory filing follows the system's initial FDA clearance for aesthetic procedures and the recent initiation of nationwide commercial distribution.
Upon receiving FDA clearance for power liposuction, the expanded functionality would position AYON as what the company describes as "the new gold standard in surgical aesthetics," offering comprehensive body contouring treatments through a single integrated platform.