510(k) · Cleared

Recalled · 2010

Soundvaser System

K022051510(k) TraditionalCleared Sep 11, 200279-day reviewClass II21 CFR 878.5040Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sound Surgical Technologies, LLC · QPB System, Suction, Lipoplasty For Removal

Cleared on Sep 11, 2002 as substantially equivalent to K991791 (Sound Surgical Technologies, LLC, 1999) and 4 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1991. 48 later devices descend from it. It has been recalled 2 times.

Decided: Sep 11, 2002
Review: 79 days
Class: Class II
Product code: QPB
Recalls: 2
Predicates: 5

Its longest line of descent runs back 3 generations to K910696 (1991). 18 ancestors in all, the oldest K884413 (1988). 48 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
2 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
1 generation backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
This deviceK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002
Descendant · cites it directly · 36 of its ownK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
Descendant · 2 generations on · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
Descendant · 3 generations on · 17 of its ownK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled
Descendant · 3 generations on · 12 of its ownK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
Descendant · 4 generations on · 11 of its ownK120902 GID 700The Gid Group, Inc. · 2012 · Recalled

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2004high 7 (2012) · low 0 (2006)2026

Most influential descendants

Showing 5 of 48 · See all

K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004 · cites it directly36descendants
K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · 2 generations on34descendants
K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · 3 generations on17descendants
K081848Lipose Fat Transfer SystemLipose Corp. · 2008 · 3 generations on12descendants
K120902GID 700The Gid Group, Inc. · 2012 · 4 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K910696	Cusa (R) System 200C/200T/200M/200H Ultra Aspirator	Valleylab, Inc.	1991	—
−2	K970471	Mentor Ultrasound Assisted Tissue Removal System (TRS)	Mentor Corp.	1997	—
−1	K983065	Mentor Ultrasound-Assisted Tissue Removal System	Mentor Corp.	1998	—
0 (this device)	K022051	Soundvaser System	Sound Surgical Technologies, LLC	2002	—
+1	K042261	Macropore Puricel Lipoplasty System	Macropore Biosurgery, Inc.	2004	—
+2	K072587	Cytori Aft System	Cytori Therapeutics, Inc.	2007	—
+3	K092482	Tissu Trans Filtron, Models 3-TT-Filtron 2000-500	Shippert Medical Technologies Corp.	2009	8
+3	K081848	Lipose Fat Transfer System	Lipose Corp.	2008	—
+4	K120902	GID 700	The Gid Group, Inc.	2012	1

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
2004	2	0
2005	1	0
2007	2	0
2008	1	0
2009	2	0
2010	5	0
2011	1	0
2012	7	0
2013	1	0
2014	4	0
2015	2	0
2016	1	0
2017	5	0
2018	1	0
2019	4	0
2020	2	0
2021	2	0
2022	1	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K022051, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K991791	Sound Vaser System Summary page 6 …at the FDA has determined to be substantially equivalent to pre-amendment devices as depicted below: u Sound Surgical Technologies, The SoundVASER System, K99179 1 o Sound Surgical Technologies, The SoundVASER System, K993868 o Mentor Corporation, The Contour Genesis System,…	Sound Surgical Technologies, LLC	1999	2
*	K993868	The Soundvaser Dissection System Summary page 6 …mendment devices as depicted below: u Sound Surgical Technologies, The SoundVASER System, K99179 1 o Sound Surgical Technologies, The SoundVASER System, K993868 o Mentor Corporation, The Contour Genesis System, K970471 o Mentor Corporation, The Contour Genesis System, K98…	Sound Surgical Technologies, LLC	1999	2
*	K970471	Mentor Ultrasound Assisted Tissue Removal System (TRS) Summary page 6 …logies, The SoundVASER System, K99179 1 o Sound Surgical Technologies, The SoundVASER System, K993868 o Mentor Corporation, The Contour Genesis System, K970471 o Mentor Corporation, The Contour Genesis System, K983065 o Mentor Corporation, The Contour Genesis System, KO0…	Mentor Corp.	1997	—
*	K983065	Mentor Ultrasound-Assisted Tissue Removal System Summary page 6 …echnologies, The SoundVASER System, K993868 o Mentor Corporation, The Contour Genesis System, K970471 o Mentor Corporation, The Contour Genesis System, K983065 o Mentor Corporation, The Contour Genesis System, KO04005 Device Description The SoundVASER System is comprised…	Mentor Corp.	1998	—
*	K004005	Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis…	Mentor Corp.	2001	—

What descends from it? (48)

See all 48

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042261	Macropore Puricel Lipoplasty System	Macropore Biosurgery, Inc.	2004	36
K110306	Sound Surgical Vaser 2.1 Lipo System	Sound Surgical Technologies, LLC	2011	5
K041058	Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems	Misonix, Inc.	2004	4
K113128	Microaire Surgical Instruments LLC	Microaire Surgical Instruments, LLC	2012	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 21, 2010	Not classified	Z-0939-2011	Process control	Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
Dec 28, 2007	Not classified	Z-0933-2008	Device Design	Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
3 of the 18 ancestors have a recall of any class.
Of its descendants, K042261 (Macropore Biosurgery, Inc., 2004) has gone furthest, with 36 descendants of its own.

How does its category compare?

All QPB devices

QPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QPB

5so far in 2026, the most since 2007

2007high 5 (2026) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QPB

194in 2024

2007high 238 (2026) · low 69 (2008)2026

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

2007high 28 (2023) · low 0 (2007)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	MAUDE reports
2007	2	—	0
2008	4	69	0
2009	1	—	0
2010	2	—	0
2011	2	—	0
2012	3	234	0
2013	0	—	0
2014	1	—	0
2015	1	—	0
2016	1	—	0
2017	3	112	0
2018	0	—	0
2019	2	—	0
2020	2	—	0
2021	0	—	0
2022	2	—	5
2023	0	—	28
2024	4	194	16
2025	2	—	16
2026	5	238	—

What is it indicated for?

The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

Neurosurgery

Gastrointestinal and Affiliated Organ Surgery

Urological Surgery

Plastic and Reconstructive Surgery

General Surgery

Orthopedic Surgery

Gynecological Surgery

Thoracic Surgery

Laparoscopic Surgery

The SoundVASER System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

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/K022051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022051: Soundvaser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022051

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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