510(k) Report

510(k) · Cleared

Cleared

Lssa (NP-200)

K252495510(k) TraditionalCleared Apr 3, 2026238-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

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

Cleared on Apr 3, 2026 as substantially equivalent to K212969 (Lhbiomed Co., Ltd., 2024) after a 238-day review. Its family tree reaches back 7 generations to 1991.

Decided
Apr 3, 2026
Review
238 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K910696 (1991). 22 ancestors in all, the oldest K884413 (1988). No later device cites it as a predicate yet.

  1. Root · 7 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
  2. 6 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
  3. 5 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
  4. 4 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
  5. 3 generations backK110306 Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC · 2011 · Recalled
  6. 2 generations backK190551 VASERlipo SystemSolta Medical · 2019
  7. 1 generation backK212969 LiposaverLhbiomed Co., Ltd. · 2024
  8. This deviceK252495 Lssa (NP-200)Newpong Co., Ltd. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K910696Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc.1991—
−6K970471Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp.1997—
−5K983065Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp.1998—
−4K022051Soundvaser SystemSound Surgical Technologies, LLC20022
−3K110306Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC20111
−2K190551VASERlipo SystemSolta Medical2019—
−1K212969LiposaverLhbiomed Co., Ltd.2024—
0 (this device)K252495Lssa (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
FIG. 1 — Lineage of K252495, 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K212969Liposaver
Summary page 5
….5040 6) Class of device : Class II 7) Panel : General & Plastic Surgery 4. Predicate Devices 1) Trade name (Predicate Submission Number): LipoSaver™ (K212969) 2) Manufacturer: LHbiomed Co., Ltd. 5. Device description LSSA (NP-200)of Newpong Co., Ltd. is an ultrasonic surg…
Lhbiomed Co., Ltd.2024—

What descends from it?

No later submission names this one as a predicate yet.

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 35 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
  • 5 of the 22 ancestors have a recall of any class.

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. 2026, 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?

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

- Plastic and Reconstruction Surgery

- Orthopedic Surgery

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K252495: Lssa (NP-200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252495

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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