Apyx Medical Announces FDA Clearance for AYON Body Contouring System

What Happened Apyx Medical Corp. (APYX) announced in a Form 8-K filed May 11, 2026 (Item 8.01) that the U.S. Food and Drug Administration has cleared the AYON Body Contouring SystemTM to include power liposuction. The company attached a press release describing the clearance as Exhibit 99.1 to the filing.

Key Details

• Date of filing: May 11, 2026 (Form 8-K, Item 8.01).
• Regulatory action: FDA clearance to expand the AYON Body Contouring SystemTM indication to include power liposuction.
• Disclosure: Press release dated May 11, 2026 is attached as Exhibit 99.1 to the 8-K.
• Filing items: Other Events (Item 8.01) and Exhibits (Item 9.01) were reported.

Why It Matters This FDA clearance formally expands the clinical use of Apyx’s AYON system to cover power liposuction procedures, potentially broadening the device’s market opportunities and clinical applications. For investors, the clearance is a regulatory milestone that could support commercial adoption and product positioning in the body-contouring market; the company’s official press release (Exhibit 99.1) provides the primary public disclosure.