# K244050: AYON Body Contouring System (AYON SYSTEM)

- Pathway: 510(k) (Traditional)
- Applicant: Apyx Medical Corporation
- Decided: May 12, 2025 after 132 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: 5 generations back to K910696 (1991). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110306: Sound Surgical Vaser 2.1 Lipo System, Sound Surgical Technologies, LLC (2011) Summary page 5.

## Most influential descendants
- K254135: LipoSurg ARTIST (2026), 0 descendants of its own

## Indications for use
The AYON Body Contouring System is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring. • The AYON Ultrasound Sub-System is used for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. • The AYON Infiltration and Aspiration Sub-System(s) are used for the infiltration and suction / aspiration of fluids and tissue during surgical procedures. Infiltration and Suction is designed to operate as a stand-alone function.

Source page: https://510kreport.com/device/K244050
Methodology: https://510kreport.com/methodology