510(k) · Cleared
ClearedLipoSurg ARTIST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nouvag AG · QPB System, Suction, Lipoplasty For Removal
Cleared on Sep 5, 2026 as substantially equivalent to K244050 (Apyx Medical Corporation, 2025) and 1 other predicate after a 257-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Sep 5, 2026
- Review
- 257 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K910696 (1991). 31 ancestors in all, the oldest K832274 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 5 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 4 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 3 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 2 generations backK110306 Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC · 2011 · Recalled
- 1 generation backK244050 AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation · 2025
- This deviceK254135 LipoSurg ARTISTNouvag AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −5 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −4 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −3 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −2 | K110306 | Sound Surgical Vaser 2.1 Lipo System | Sound Surgical Technologies, LLC | 2011 | 1 |
| −1 | K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | 2025 | — |
| 0 (this device) | K254135 | LipoSurg ARTIST | Nouvag AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K244050 | AYON Body Contouring System (AYON SYSTEM)Summary page 5…Regulatory Class: II Prescription or OTC Use: Rx Only Primary Predicate Submission Number: K244050 Device: Manufacturer: Apyx Medical Corporation Trade Name:… | 2025 |
| * | K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252…Summary page 6…K254135 Page 2 of 10 Additional Predicate Submission Number: K053451 Device: Manufacturer: Moeller Medical Gmbh & Co. Kg Trade Name:… | 2006 |
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 35 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 5 of the 31 ancestors have a recall of any class.
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 NOUVAG LipoSurg ARTIST is indicated for removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254135: LipoSurg ARTIST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254135
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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