510(k) · Cleared

Cleared

Fiberlase C02 Laser Waveguide

K100384510(k) SpecialCleared Apr 12, 201055-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

Lumenis, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Apr 12, 2010 as substantially equivalent to K921671 (Surgical Products Corp., 1992) after a 55-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it.

Decided: Apr 12, 2010
Review: 55 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K921671 (1992). 5 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK921671 Surgilase Fiberlase VCO2 Laser WaveguideSurgical Products Corp. · 1992
This deviceK100384 Fiberlase C02 Laser WaveguideLumenis, Ltd. · 2010
Descendant · cites it directly · 1 of its ownK203799 ProFlex CO2 Laser FiberInnovaquartz, LLC · 2021
Descendant · cites it directly · 1 of its ownK112166 Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering · 2011
Descendant · 2 generations on · 0 of its ownK243588 Single Use CO2 Laser Fiber (HAF005001)Quanta System Spa · 2025
Descendant · cites it directly · 0 of its ownK211761 UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering · 2021
Descendant · cites it directly · 0 of its ownK130164 Fiberlase Endure CO2 FiberLumenis, Ltd. · 2013 · Recalled

Most influential descendants

Showing 5 of 5 · See all

K203799ProFlex CO2 Laser FiberInnovaquartz, LLC · 2021 · cites it directly1descendant
K112166Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering · 2011 · cites it directly1descendant
K243588Single Use CO2 Laser Fiber (HAF005001)Quanta System Spa · 2025 · 2 generations on0descendants
K211761UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering · 2021 · cites it directly0descendants
K130164Fiberlase Endure CO2 FiberLumenis, Ltd. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921671	Surgilase Fiberlase VCO2 Laser Waveguide	Surgical Products Corp.	1992	—
0 (this device)	K100384	Fiberlase C02 Laser Waveguide	Lumenis, Ltd.	2010	—
+1	K203799	ProFlex CO2 Laser Fiber	Innovaquartz, LLC	2021	—
+1	K112166	Ultralase Flexible CO2 Laser Waveguide	W and R Investments Dba Laser Engineering	2011	—
+2	K243588	Single Use CO2 Laser Fiber (HAF005001)	Quanta System Spa	2025	—
+1	K211761	UltraLase Flexible CO2 Laser Waveguide	W & R Investments, LLC Dba Laser Engineering	2021	—
+1	K130164	Fiberlase Endure CO2 Fiber	Lumenis, Ltd.	2013	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0
2021	2	0
2025	1	0

FIG. 1 — Lineage of K100384, 1992–2025Source: 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
*	K921671	Surgilase Fiberlase VCO2 Laser Waveguide Summary page 1 …vice: ~Device Manfacturer 510(k) No. C02 Laser Waveud Sriase Inc. (acquired by Lumenis Ltd.) K921671 4. Intended Use The C02 Laser WaveGuide Delivery System is intended for use in open and laparoscopic surgical pr…	Surgical Products Corp.	1992	—

Also cleared against K921671: 2 other devices →

What descends from it? (5)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K203799	ProFlex CO2 Laser Fiber	Innovaquartz, LLC	2021	1
K112166	Ultralase Flexible CO2 Laser Waveguide	W and R Investments Dba Laser Engineering	2011	1
K211761	UltraLase Flexible CO2 Laser Waveguide	W & R Investments, LLC Dba Laser Engineering	2021	0
K130164	Fiberlase Endure CO2 Fiber	Lumenis, Ltd.	2013	0

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?

Its one ancestor has no recall.
Of its descendants, K203799 (Innovaquartz, LLC, 2021) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K921671.

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. 2010, 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 FiberLase C02 Laser WaveGuide is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase C02 Laser WaveGuide is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endloscopic procedures. The device is limited to carbon dioxide lasers having a SMA-905 connector.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100384 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100384: Fiberlase C02 Laser Waveguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100384

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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