# K253396: AYON Body Contouring System™  (AYON SYSTEM)

- Pathway: 510(k) (Traditional)
- Applicant: Apyx Medical Corporation
- Decided: May 8, 2026 after 220 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K895761 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212024: PAL System, Microaire Surgical Instruments, LLC (2022) Summary page 5.

## Indications for use
The AYON T M Power Liposuction Sub-System is used for aesthetic body contouring.

Source page: https://510kreport.com/device/K253396
Methodology: https://510kreport.com/methodology