510(k) · Cleared
Recalled · Class II · 2017Sound Surgical Vaser 2.1 Lipo System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sound Surgical Technologies, LLC · QPB System, Suction, Lipoplasty For Removal
Cleared on Jun 23, 2011 as substantially equivalent to K022051 (Sound Surgical Technologies, LLC, 2002) after a 141-day review. Its family tree reaches back 4 generations to 1991. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 2011
- Review
- 141 days
- Class
- Class II
- Product code
- QPB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910696 (1991). 19 ancestors in all, the oldest K884413 (1988). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 3 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 2 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 1 generation backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- This deviceK110306 Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC · 2011
- Descendant · cites it directly · 2 of its ownK190551 VASERlipo SystemSolta Medical · 2019
- Descendant · cites it directly · 1 of its ownK244050 AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation · 2025
- Descendant · 2 generations on · 1 of its ownK212969 LiposaverLhbiomed Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK254135 LipoSurg ARTISTNouvag AG · 2026
- Descendant · 3 generations on · 0 of its ownK252495 Lssa (NP-200)Newpong Co., Ltd. · 2026
Most influential descendants
Showing 5 of 5 · See all- K190551VASERlipo SystemSolta Medical · 2019 · cites it directly2descendants
- K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation · 2025 · cites it directly1descendant
- K212969LiposaverLhbiomed Co., Ltd. · 2024 · 2 generations on1descendant
- K254135LipoSurg ARTISTNouvag AG · 2026 · 2 generations on0descendants
- K252495Lssa (NP-200)Newpong Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −3 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −2 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −1 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| 0 (this device) | K110306 | Sound Surgical Vaser 2.1 Lipo System | Sound Surgical Technologies, LLC | 2011 | — |
| +1 | K190551 | VASERlipo System | Solta Medical | 2019 | — |
| +1 | K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | 2025 | — |
| +2 | K212969 | Liposaver | Lhbiomed Co., Ltd. | 2024 | — |
| +2 | K254135 | LipoSurg ARTIST | Nouvag AG | 2026 | — |
| +3 | K252495 | Lssa (NP-200) | Newpong Co., Ltd. | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K022051 | Soundvaser SystemSummary page 5…Predicate51 0(k) PredicateManufacturer EquivalentDevices: Number and Model Sound VASER 2.1 K022051 Sound Surgical Technologies Lipo System LLC / Sound VASER… | 2002 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2017 | Class II | Z-3047-2017 | Equipment maintenance | Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K190551 (Solta Medical, 2019) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K022051.
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. 2011, 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 Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. The Sound Surgical VentX 2.1 is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX 2.1 is designed to operate with the Sound Surgical VASER 2.1 or as a stand-alone system. The Sound Surgical VASER 2.1 Lipo System is intended for the fragmentation, emulsification and…
Read the full statement (130 words)
The Sound Surgical VASER 2.1 is intended for the
fragmentation and emulsification of subcutaneous fatty tissues
for aesthetic body contouring.
The Sound Surgical VentX 2.1 is intended for the suction or
aspiration of fluids and tissue during surgical procedures. The
VentX 2.1 is designed to operate with the Sound Surgical
VASER 2.1 or as a stand-alone system.
The Sound Surgical VASER 2.1 Lipo System is intended for the
fragmentation, emulsification and aspiration of subcutaneous
fatty tissue for the purpose of aesthetic body contouring.
The Sound Surgical VASER 2.1 Lipo System is also indicated
for use in the following surgical specialties for the
fragmentation, emulsification and aspiration of soft tissues:
Nuerosurgery;
Gastrointestinal and affiliated organ surgery;
Urological surgery;
Plastic and reconstructive surgery;
General surgery
Gynecological surgery:
Thoracic surgery; and
Laparoscopic surgery.
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/K110306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110306: Sound Surgical Vaser 2.1 Lipo System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110306
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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