510(k) · Cleared

Cleared

Coherent Holmium:Yag Surgical Laser

K902990510(k) TraditionalCleared Oct 2, 199085-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

Coherent Medical Division · GEX Powered Laser Surgical Instrument

Cleared on Oct 2, 1990 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 484 later devices descend from it.

Decided: Oct 2, 1990
Review: 85 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

484 later devices descend from it, 3 citing it directly.

This deviceK902990 Coherent Holmium:Yag Surgical LaserCoherent Medical Division · 1990
Descendant · cites it directly · 483 of its ownK960413 Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc. · 1996
Descendant · cites it directly · 351 of its ownK980685 Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc. · 1998
Descendant · cites it directly · 350 of its ownK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
Descendant · 2 generations on · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
Descendant · 2 generations on · 225 of its ownK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled

Showing 5 of 484 descendants. See all descendants

Descendants cleared per year

1996high 42 (2025) · low 0 (1997)2026

Most influential descendants

Showing 5 of 484 · See all

K960413Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc. · 1996 · cites it directly483descendants
K980685Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc. · 1998 · cites it directly351descendants
K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc. · 1999 · cites it directly350descendants
K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · 2 generations on342descendants
K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · 2 generations on225descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K902990	Coherent Holmium:Yag Surgical Laser	Coherent Medical Division	1990	—
+1	K960413	Coherent Slimline Single Lumen Aspiration Needle Kit	Lumenis, Inc.	1996	—
+1	K980685	Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers	Lumenis, Inc.	1998	—
+1	K990947	Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…	Lumenis, Inc.	1999	—
+2	K011703	Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…	Lumenis	2001	2
+2	K050738	FT Fiber Optic Delivery Systems	Fibertech GmbH	2005	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0
1999	1	0
2001	2	0
2002	8	0
2003	3	0
2004	3	0
2005	5	0
2006	4	0
2007	4	0
2008	18	0
2009	8	0
2010	20	0
2011	18	0
2012	23	0
2013	24	0
2014	23	0
2015	24	0
2016	33	0
2017	18	0
2018	22	0
2019	16	0
2020	27	0
2021	20	0
2022	30	0
2023	24	0
2024	31	0
2025	42	0
2026	30	0

FIG. 1 — Lineage of K902990, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (484)

See all 484

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

Number	Device	Applicant	Decided	Descendants
K960413	Coherent Slimline Single Lumen Aspiration Needle Kit	Lumenis, Inc.	1996	483
K980685	Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers	Lumenis, Inc.	1998	351
K990947	Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…	Lumenis, Inc.	1999	350

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, K960413 (Lumenis, Inc., 1996) has gone furthest, with 483 descendants 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.

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	—

https://510kreport.com/device/K902990 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902990: Coherent Holmium:Yag Surgical Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902990

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026