Apyx Medical Seeks FDA Clearance For Expanded Use Of AYON Body Contouring System

(RTTNews) - Apyx Medical Corporation (APYX) on Monday said it has submitted a new 510(k) premarket notification to the U.S. Food and Drug Administration seeking to expand the label of its AYON Body Contouring System to include power liposuction.

The AYON system, which is already FDA-cleared, integrates fat removal, tissue contraction, contouring, and electrosurgical functions in a single platform.

A 510(k) premarket notification is a submission to the FDA demonstrating that a new medical device is substantially equivalent to a legally marketed one.

"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.