510(k) · Cleared
ClearedVASERlipo System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solta Medical · QPB System, Suction, Lipoplasty For Removal
Cleared on May 1, 2019 as substantially equivalent to K110306 (Sound Surgical Technologies, LLC, 2011) after a 57-day review. Its family tree reaches back 5 generations to 1991. 2 later devices descend from it.
- Decided
- May 1, 2019
- Review
- 57 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). 2 later devices descend 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 deviceK190551 VASERlipo SystemSolta Medical · 2019
- Descendant · cites it directly · 1 of its ownK212969 LiposaverLhbiomed Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK252495 Lssa (NP-200)Newpong Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | K190551 | VASERlipo System | Solta Medical | 2019 | — |
| +1 | K212969 | Liposaver | Lhbiomed Co., Ltd. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 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…rences: 21 CFR 878.5040 Product Codes: MUU Performance Standards: No performance standards for this device. 3. Predicate Device K110306 VASERlipo System 4. Product Description The subject of this Special 510(k) submission is for the VASERlipo System which is… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212969 | Liposaver | 2024 | 1 |
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 28 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, K212969 (Lhbiomed Co., Ltd., 2024) has gone furthest, with 1 descendant 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. 2019, 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 VASERIlipo System is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. The VentX console is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX console is designed to operate with the VASERIlipo System or as a stand-alone system. The VASERlIipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue…
Read the full statement (127 words)
The VASERIlipo System is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring.
The VentX console is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX console is designed to operate with the VASERIlipo System or as a stand-alone system.
The VASERlIipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.
The VASERIipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues:
* Neurosurgery
« Gastrointestinal and affiliated organ surgery
« Urological surgery
« Plastic and reconstructive surgery
* General surgery
* Orthopedic 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/K190551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190551: VASERlipo System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190551
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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