510(k) · Cleared
ClearedAYON Body Contouring System (AYON SYSTEM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apyx Medical Corporation · QPB System, Suction, Lipoplasty For Removal
Cleared on May 12, 2025 as substantially equivalent to K110306 (Sound Surgical Technologies, LLC, 2011) after a 132-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- May 12, 2025
- Review
- 132 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910696 (1991). 20 ancestors in all, the oldest K884413 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 4 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 3 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 2 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 1 generation backK110306 Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC · 2011 · Recalled
- This deviceK244050 AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation · 2025
- Descendant · cites it directly · 0 of its ownK254135 LipoSurg ARTISTNouvag AG · 2026
Most influential descendants
Showing 1 of 1 · See all- K254135LipoSurg ARTISTNouvag AG · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −4 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −3 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −2 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −1 | K110306 | Sound Surgical Vaser 2.1 Lipo System | Sound Surgical Technologies, LLC | 2011 | 1 |
| 0 (this device) | K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | 2025 | — |
| +1 | K254135 | LipoSurg ARTIST | Nouvag AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QPB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QPB device
- #1 K212024 PAL Systemscore 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110306 | Sound Surgical Vaser 2.1 Lipo SystemSummary page 5…Lipoplasty System Product Code QPB Predicate Device: VASER 2.1 Lipo System (K110306) 2. Proposed Indications for Use The AYON Body Contouring System is intended for the fragmentation, emulsification, and… | 2011 |
| † | K161722 | Vitruvian Ultimate Aspirator | 2016 |
| † | K981215 | Psi-Tec Liposuction Aspirator | 1998 |
| † | K031432 | Klein Surgical Infiltration Pump, Model Kip-II | 2003 |
| † | K991437 | Wells Johnson Infusion System, Model 20-6000-00 | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254135 | LipoSurg ARTIST | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K254135 (Nouvag AG, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K110306.
How does its category compare?
All QPB devicesQPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QPB
5so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QPB
194in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QPB
No recall names QPB since 2007.
Adverse event reports per year · QPB
16in 2025
MAUDE reports naming product code QPB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 4 | 69 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 234 | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 4 | 194 | 0 | 16 |
| 2025 | 2 | — | 0 | 16 |
| 2026 | 5 | 238 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K244050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244050: AYON Body Contouring System (AYON SYSTEM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244050
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026