Apyx Medical Corporation has announced the submission of a new 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking label expansion for its AYON Body Contouring System™ to include power liposuction. This regulatory review, if successful, would allow the AYON system to offer power liposuction functionality, making it the first fully integrated body contouring platform. The company has not yet received FDA clearance and is currently undergoing the regulatory review process. No grants or funding from multiple organizations were mentioned in the announcement.
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