510(k) · Cleared

Cleared

Cook Holmium Laser Fiber

K133788510(k) TraditionalCleared Mar 18, 2015461-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

Cook Incorporated · GEX Powered Laser Surgical Instrument

Cleared on Mar 18, 2015 as substantially equivalent to K124030 (Cook Incorporated, 2013) after a 461-day review. Its family tree reaches back 3 generations to 1999.

Decided: Mar 18, 2015
Review: 461 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K992866 (1999). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK992866 Optilite IX Laser Surgery AccessoriesConvergent Laser Technologies · 1999 · Recalled
2 generations backK073496 Optilite Holmium Laser FibersCook Urological, Inc. · 2008 · Recalled
1 generation backK124030 Cook Holmium Laser FiberCook Incorporated · 2013 · Recalled
This deviceK133788 Cook Holmium Laser FiberCook Incorporated · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K992866	Optilite IX Laser Surgery Accessories	Convergent Laser Technologies	1999	2
−2	K073496	Optilite Holmium Laser Fibers	Cook Urological, Inc.	2008	1
−1	K124030	Cook Holmium Laser Fiber	Cook Incorporated	2013	1
0 (this device)	K133788	Cook Holmium Laser Fiber	Cook Incorporated	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K133788, 1999–2015Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K124030	Cook Holmium Laser Fiber Summary page 4 …assification: Class II Regulation: 21 CFR §878.4810 Product Code: GEX Predicate Device: Cook Holmium Laser Fiber K124030, July 1, 2013 K133788…	Cook Incorporated	2013	1

Also cleared against K124030: 1 other device →

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 16 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
3 of the 4 ancestors have a recall of any class.
1 other device also cites its predicate K124030.

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. 2015, 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?

Used for incision/excision, ablation, and coagulation (hemostasis) when attached to a cleared Ho:YAG laser system comprised of any standard SMA-type connector and an output power of up to 100 watts, for the indications for which the system has been cleared.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133788 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133788: Cook Holmium Laser Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133788

Report an extraction error

Are you the manufacturer?

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