510(k) · Cleared

Recalled · Class II · 2025

Fiberlase Endure CO2 Fiber

K130164510(k) SpecialCleared Mar 24, 201360-day reviewClass II21 CFR 878.4810Recalls 1

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

Lumenis, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Mar 24, 2013 as substantially equivalent to K100384 (Lumenis, Ltd., 2010) after a 60-day review. Its family tree reaches back 2 generations to 1992. It has been recalled once.

Decided: Mar 24, 2013
Review: 60 days
Class: Class II
Product code: GEX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K921671 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK921671 Surgilase Fiberlase VCO2 Laser WaveguideSurgical Products Corp. · 1992
1 generation backK100384 Fiberlase C02 Laser WaveguideLumenis, Ltd. · 2010
This deviceK130164 Fiberlase Endure CO2 FiberLumenis, Ltd. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K921671	Surgilase Fiberlase VCO2 Laser Waveguide	Surgical Products Corp.	1992	—
−1	K100384	Fiberlase C02 Laser Waveguide	Lumenis, Ltd.	2010	—
0 (this device)	K130164	Fiberlase Endure CO2 Fiber	Lumenis, Ltd.	2013	—

FIG. 1 — Lineage of K130164, 1992–2013Source: 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 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K100384	Fiberlase C02 Laser Waveguide Summary page 2 …Device Name 51kN Date of Clearance FiberLase C02 Laser WaveGuide IK1003 84 A 6112 ,2010 Performance Standards FiberLose Endure C02 Fiber was tested and complies with the…	Lumenis, Ltd.	2010	—

Also cleared against K100384: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 22, 2025	Class II	Z-2344-2025	Nonconforming Material/Component	The potential for unsterilized product within finished product labeled as sterile.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 17.8 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K100384.

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. 2013, 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 FiberLose Endure C02 Fiber is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. FiberLose Endure C02 Fiber is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130164 · printed Nov 5, 2026

Cite this page

510(k) Report. “K130164: Fiberlase Endure CO2 Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130164

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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