510(k) Report

510(k) · Cleared

Cleared

Liposaver

K212969510(k) TraditionalCleared Aug 7, 20241,056-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

Lhbiomed Co., Ltd. · QPB System, Suction, Lipoplasty For Removal

Cleared on Aug 7, 2024 as substantially equivalent to K190551 (Solta Medical, 2019) after a 1,056-day review. Its family tree reaches back 6 generations to 1991. 1 later device descends from it.

Decided
Aug 7, 2024
Review
1,056 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K910696 (1991). 21 ancestors in all, the oldest K884413 (1988). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 3 other ancestors1998: 2 other ancestors1997: 2 other ancestors1996: 2 other ancestors1992: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor1988: 1 other ancestor2026: 1 descendant clearedK910696 · Cusa (R) System 200C/200T/200M/200H Ultra Aspirator · Valleylab, Inc. · 1991K970471 · Mentor Ultrasound Assisted Tissue Removal System (TRS) · Mentor Corp. · 1997K983065 · Mentor Ultrasound-Assisted Tissue Removal System · Mentor Corp. · 1998K022051 · Soundvaser System · Sound Surgical Technologies, LLC · 2002 · recalledK110306 · Sound Surgical Vaser 2.1 Lipo System · Sound Surgical Technologies, LLC · 2011 · recalledK190551 · VASERlipo System · Solta Medical · 20191990200020102020
  1. Root · 6 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
  2. 5 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
  3. 4 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
  4. 3 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
  5. 2 generations backK110306 Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC · 2011 · Recalled
  6. 1 generation backK190551 VASERlipo SystemSolta Medical · 2019
  7. This deviceK212969 LiposaverLhbiomed Co., Ltd. · 2024
  8. Descendant · cites it directly · 0 of its ownK252495 Lssa (NP-200)Newpong Co., Ltd. · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K252495Lssa (NP-200)Newpong Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K910696Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc.1991—
−5K970471Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp.1997—
−4K983065Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp.1998—
−3K022051Soundvaser SystemSound Surgical Technologies, LLC20022
−2K110306Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC20111
−1K190551VASERlipo SystemSolta Medical2019—
0 (this device)K212969LiposaverLhbiomed Co., Ltd.2024—
+1K252495Lssa (NP-200)Newpong Co., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199210
199410
199520
199620
199720
199820
199930
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K212969, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K212024 PAL Systemscore 13.7 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K190551VASERlipo System
Summary page 4
…s II Panel : General & Plastic Surgery Model name: LS-1000, LS-2000 3. Predicate Device The legally marketed device to which we are claiming equivalence : K190551, VASERlipo System Classification System, Suction, Lipoplasty Product Code: MUU Regulation Number: 21 CFR 878.5040 Cla…
Solta Medical2019—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K252495Lssa (NP-200)Newpong Co., Ltd.20260

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 33 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
  • 5 of the 21 ancestors have a recall of any class.
  • Of its descendants, K252495 (Newpong Co., Ltd., 2026) has gone furthest, with 0 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. 2024, this device’s year, is highlighted.

FDA decisions per year · QPB

5so far in 2026, the most since 2007

2007: 22008: 42009: 12010: 22011: 22012: 32014: 12015: 12016: 12017: 32019: 22020: 22022: 22024: 42025: 22026 (partial year): 5
2007high 5 (2026) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QPB

194in 2024

2008: 69 days median2012: 234 days median2017: 112 days median2024: 194 days median2026 (partial year): 238 days median
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

2022: 52023: 282024: 162025: 16
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200846900
20091—00
20102—00
20112—00
2012323400
20130—00
20141—00
20151—00
20161—00
2017311200
20180—00
20192—00
20202—00
20210—00
20222—05
20230—028
20244194016
20252—016
202652380—

What is it indicated for?

Liposaver™ is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. Liposaver™ is indicated for use in the following surgical specialists when the fragmentation and aspiration of soft tissue is desired:

- Plastic and Reconstruction Surgery

- Orthopedic Surgery

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K212969: Liposaver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K212969

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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