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 8, 2026 as substantially equivalent to K212024 (Microaire Surgical Instruments, LLC, 2022) after a 220-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- May 8, 2026
- Review
- 220 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K895761 (1989). 11 ancestors in all, the oldest K832274 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK895761 General AsperatorKolster Methods · 1989
- 5 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
- 4 generations backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
- 3 generations backK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
- 2 generations backK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
- 1 generation backK212024 PAL SystemMicroaire Surgical Instruments, LLC · 2022
- This deviceK253396 AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| −5 | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| −4 | K981215 | Psi-Tec Liposuction Aspirator | Byron Medical | 1998 | — |
| −3 | K032802 | HK Liposuction Aspirator, Model AP-Iii & AP230-Iii | Hk Surgical, Inc. | 2003 | — |
| −2 | K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model… | Moeller Medical GmbH & Co. KG | 2006 | — |
| −1 | K212024 | PAL System | Microaire Surgical Instruments, LLC | 2022 | — |
| 0 (this device) | K253396 | AYON Body Contouring System™ (AYON SYSTEM) | Apyx Medical Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K212024 | PAL SystemSummary page 5…8.5040 - Suction Lipoplasty System Product Code QPB Predicate Device: PAL System (K212024) by MicroAire Surgical Instruments, LLC 2. Proposed Indications for Use The AYON™ Po… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 6 companies; a new generation was cleared every 5.4 years on median.
- None of the 11 ancestors has a recall.
- 2 other devices also cite its predicate K212024.
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. 2026, 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 T M Power Liposuction Sub-System is used for aesthetic body contouring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253396 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253396: AYON Body Contouring System™ (AYON SYSTEM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253396
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026