510(k) · Cleared

Cleared

Powerlipo Laser System

K082096510(k) TraditionalCleared Oct 8, 200876-day reviewClass II21 CFR 878.4810

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

Lutronic Corporation · GEX Powered Laser Surgical Instrument

Cleared on Oct 8, 2008 after a 76-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Oct 8, 2008
Review: 76 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK082096 Powerlipo Laser SystemLutronic Corporation · 2008
Descendant · cites it directly · 1 of its ownK101573 Accusculpt II Laser SystemLutronic Corporation · 2010
Descendant · 2 generations on · 0 of its ownK212270 DEKA LipoAIEl.En Electronic Engineering Spa · 2021

Most influential descendants

Showing 2 of 2 · See all

K101573Accusculpt II Laser SystemLutronic Corporation · 2010 · cites it directly1descendant
K212270DEKA LipoAIEl.En Electronic Engineering Spa · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K082096	Powerlipo Laser System	Lutronic Corporation	2008	—
+1	K101573	Accusculpt II Laser System	Lutronic Corporation	2010	—
+2	K212270	DEKA LipoAI	El.En Electronic Engineering Spa	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2021	1	0

FIG. 1 — Lineage of K082096, 2008–2021Source: 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 GEX? 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 GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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? (4)

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	Recalls
*	—	SmartLipo Laser System Named without a submission number	—
*	—	SmartLipo Multiwavelength Laser System Named without a submission number	—
*	—	Cynosure YAG MIR II Laser Named without a submission number	—
*	—	CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser Named without a submission number	—

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
K101573	Accusculpt II Laser System	Lutronic Corporation	2010	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?

Of its descendants, K101573 (Lutronic Corporation, 2010) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

The PowerLipo Laser System in indicated for the surgical incision, excision,

vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as

skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage

meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The

PowerLipo is further indicated for laser assisted lipolysis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082096 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082096: Powerlipo Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082096

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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