Apyx Medical Corporation · Class II · Cleared May 8, 2026
| K-number | K253396 |
| Device name | AYON Body Contouring System® (AYON SYSTEM) |
| Applicant | Apyx Medical Corporation |
| Product code | QPB |
| Device class | Class II |
| Decision date | May 8, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.5040 |
The AYON™ Power Liposuction Sub-System is a power-assisted liposuction device used for aesthetic body contouring. It is an electronic control system that reciprocates a cannula during lipoplasty procedures and integrates with the AYON Body Contouring System console via a touchscreen graphical user interface.
The device operates at 4000 ± 10% strokes per minute with a stroke distance of 2.8 mm (±0.4 mm), powered by AC 120 VAC at 50-60 Hz. It features two attachable handpieces with speed control via touchscreen and handpiece buttons, a 2-hour continuous use/2-hour off duty cycle, and tubing adaptors compatible with commercially available infiltration and aspiration tubing.
IEC 60601-1-1 (electrical safety), IEC 60601-1-2 and 60601-4-2 (EMC), ISO 62304 (software and cybersecurity), ISO 10993-1 (biocompatibility), ISO 17665 (reprocessing), ISO 11135 (sterility), ISO 11607 (packaging), and ISO 10079-1 and 10079-4 (tubing adaptor mechanical performance).
The subject device has identical intended use, product code, mechanism of action, and performance characteristics (speed, stroke distance, duty cycle, sterilization) to the MicroAire PAL System predicate (K212024). Both employ reciprocating cannulas for power-assisted liposuction with comparable electrical safety and control mechanisms, establishing substantial equivalence.
View the full FDA submission: accessdata.fda.gov