510(k) · Cleared
Recalled · 2007Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Misonix, Inc. · QPB System, Suction, Lipoplasty For Removal
Cleared on May 17, 2004 as substantially equivalent to K004005 (Mentor Corp., 2001) and 1 other predicate after a 24-day review. Its family tree reaches back 4 generations to 1991. 4 later devices descend from it. It has been recalled once.
- Decided
- May 17, 2004
- Review
- 24 days
- Class
- Class II
- Product code
- QPB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K910696 (1991). 19 ancestors in all, the oldest K884413 (1988). 4 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 deviceK041058 Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK052183 Soring GMBH Sonoca LipoSoring GmbH Medizintechnik · 2005
- Descendant · cites it directly · 2 of its ownK092066 Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01)…Andrew Technologies, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK121218 Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia…Andrew Technologies, LLC · 2012
- Descendant · 3 generations on · 0 of its ownK130152 Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013
Most influential descendants
Showing 4 of 4 · See all- K052183Soring GMBH Sonoca LipoSoring GmbH Medizintechnik · 2005 · cites it directly3descendants
- K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC · 2010 · cites it directly2descendants
- K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC · 2012 · 2 generations on1descendant
- K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013 · 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) | K041058 | Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems | Misonix, Inc. | 2004 | — |
| +1 | K052183 | Soring GMBH Sonoca Lipo | Soring GmbH Medizintechnik | 2005 | — |
| +1 | K092066 | Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser… | Andrew Technologies, LLC | 2010 | — |
| +2 | K121218 | Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM… | Andrew Technologies, LLC | 2012 | — |
| +3 | K130152 | Hydrasolve Lipoplasty System | Andrew Technologies, LLC | 2013 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K004005 | Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis…Summary page 5…Predicate Device Information Predicate Devices Mentor Contour Genesis Ultrasound Assisted Tissue Removal System K004005 SoundVaser System, Sound Surgical Technologies Inc. K0220… | 2001 |
| * | K022051 | Soundvaser SystemSummary page 5…Tissue Removal System K004005 SoundVaser System, Sound Surgical Technologies Inc. K022051 4. Device Description LYSONIX 2000/3000 Ultrasonic Surgical System is compris… | 2002 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Jul 27, 2007 | Not classified | Z-1230-2007 | Other | Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K052183 (Soring GmbH Medizintechnik, 2005) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K004005.
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.
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?
LYSONIX 2000/3000 Systems are indicated for the liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery Applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for the purposes 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/K041058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041058: Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041058
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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