510(k) · Cleared

Cleared

Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste Collection Kit (Was-01), Phaser Cannulae

K092066510(k) TraditionalCleared Apr 12, 2010278-day reviewClass II21 CFR 878.5040

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

Andrew Technologies, LLC · QPB System, Suction, Lipoplasty For Removal

Cleared on Apr 12, 2010 as substantially equivalent to K980292 (Alcon Laboratories, 1998) and 6 other predicates after a 278-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.

Decided: Apr 12, 2010
Review: 278 days
Class: Class II
Product code: QPB
Recalls: None
Predicates: 7

Its longest line of descent runs back 6 generations to K910696 (1991). 36 ancestors in all, the oldest K832274 (1983). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

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 backK041058 Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc. · 2004 · Recalled
1 generation backK052183 Soring GMBH Sonoca LipoSoring GmbH Medizintechnik · 2005
This deviceK092066 Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01)…Andrew Technologies, LLC · 2010
Descendant · cites it directly · 1 of its ownK121218 Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia…Andrew Technologies, LLC · 2012
Descendant · 2 generations on · 0 of its ownK130152 Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013

Most influential descendants

Showing 2 of 2 · See all

K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC · 2012 · cites it directly1descendant
K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013 · 2 generations on0descendants

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	K041058	Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems	Misonix, Inc.	2004	1
−1	K052183	Soring GMBH Sonoca Lipo	Soring GmbH Medizintechnik	2005	—
0 (this device)	K092066	Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser…	Andrew Technologies, LLC	2010	—
+1	K121218	Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM…	Andrew Technologies, LLC	2012	—
+2	K130152	Hydrasolve Lipoplasty System	Andrew Technologies, LLC	2013	—

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
1990	1	0
1991	1	0
1992	1	0
1994	2	0
1995	2	0
1996	2	0
1997	2	0
1998	6	0
1999	5	0
2001	2	0
2003	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0

FIG. 1 — Lineage of K092066, 1991–2013Source: 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

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What was it cleared against? (7)

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
*	K980292	Cataract Liquefracture Device Summary page 5 …fication Name: Suction Lipoplasty System, Class II, 21 C.F.R. § 878.5040 (MUU) Predicate Devices I1. Alcon Laboratories, Cataract Liquefracture Device (K980292) 2. Misonix Inc., Lysonix 2000/3000 Ultrasonic Surgical Aspiration Systems (K04 1058)…	Alcon Laboratories	1998	—
*	K041058	Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems Summary page 5 …lcon Laboratories, Cataract Liquefracture Device (K980292) 2. Misonix Inc., Lysonix 2000/3000 Ultrasonic Surgical Aspiration Systems (K04 1058) 3. Soring GmnbH Medizintechnik, Sonoca-Lipo (K052 183) 4. Byron Medical, PSI-Tec Liposuction Asp…	Misonix, Inc.	2004	1
*	K052183	Soring GMBH Sonoca Lipo Summary page 5 …2. Misonix Inc., Lysonix 2000/3000 Ultrasonic Surgical Aspiration Systems (K04 1058) 3. Soring GmnbH Medizintechnik, Sonoca-Lipo (K052 183) 4. Byron Medical, PSI-Tec Liposuction Aspirator (K98121I5) 5. Byron Medical , PSI-Tec Syringe In…	Soring GmbH Medizintechnik	2005	—
*	K981215	Psi-Tec Liposuction Aspirator Summary page 6 …Device (K980292); the PSI-Tec Peristaltic Infiltration Pump, Byron Medical Inc. (K040149); the Byron Medical Inc. PSI-Tec Liposuction Aspirator (K981215); the Byron Medical Inc. Byron Liposuction Aspiration and Tumnescent Infiltration Cannulae/Needles (K981…	Byron Medical	1998	—
*	K040149	Psi-Tec Peristaltic Infiltration Pump Summary page 5 …hnik, Sonoca-Lipo (K052 183) 4. Byron Medical, PSI-Tec Liposuction Aspirator (K98121I5) 5. Byron Medical , PSI-Tec Syringe Infusion Pump (K040 149) 6. Byron Medical, Liposuction Aspiration and Tumnescent Infiltration Cannulae/Needles (K981…	Byron Medical	2004	—
*	K981172	Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles Summary page 5 …cal , PSI-Tec Syringe Infusion Pump (K040 149) 6. Byron Medical, Liposuction Aspiration and Tumnescent Infiltration Cannulae/Needles (K981 172) 7. HK Surgical Inc., HK Liposuction Aspirator III (K032802) Intended Use / Indications for Use The Ph…	Byron Medical	1998	—
*	K032802	HK Liposuction Aspirator, Model AP-Iii & AP230-Iii Summary page 5 …al, Liposuction Aspiration and Tumnescent Infiltration Cannulae/Needles (K981 172) 7. HK Surgical Inc., HK Liposuction Aspirator III (K032802) Intended Use / Indications for Use The Phaser Lipoplasty System is intended to be used for liquefaction and aspiratio…	Hk Surgical, Inc.	2003	—

Also cleared against K980292: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121218	Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…	Andrew Technologies, LLC	2012	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 19 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
6 of the 36 ancestors have a recall of any class.
Of its descendants, K121218 (Andrew Technologies, LLC, 2012) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K980292.

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. 2010, this device’s year, is highlighted.

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 Phaser Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring.

The Phaser Lipoplasty System is indicated for use in 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/K092066 · printed Nov 5, 2026

Cite this page

510(k) Report. “K092066: Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste Collection Kit (Was-01), Phaser Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092066

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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