Apyx Medical (APYX) has received 510(k) clearance from the FDA for the AYON Body Contouring System. The company said it is actively preparing for a commercial launch of AYON with key surgeons in critical geographies starting in the second half of 2025.
The company said this initial 510(k) clearance for AYON covers a wide variety of aesthetic treatments, including Renuvion to address loose and lax skin, ultrasound-assisted liposuction, electrocoagulation to support procedures requiring removal of excess tissue, along with several others. The company plans to expand the cleared indications for AYON, to include power liposuction, with an additional 510(k) submission later in the current year.
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