510(k) · Cleared

Cleared

Coherent Holmium:Yag Surgical Laser

K895518510(k) TraditionalCleared Nov 30, 198979-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, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Nov 30, 1989 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 352 later devices descend from it.

Decided: Nov 30, 1989
Review: 79 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

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

This deviceK895518 Coherent Holmium:Yag Surgical LaserLumenis, Inc. · 1989
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 · 3 generations on · 136 of its ownK083616 Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009
Descendant · 3 generations on · 136 of its ownK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009

Showing 5 of 352 descendants. See all descendants

Descendants cleared per year

1998high 32 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 352 · See all

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
K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009 · 3 generations on136descendants
K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009 · 3 generations on136descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K895518	Coherent Holmium:Yag Surgical Laser	Lumenis, Inc.	1989	—
+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
+3	K083616	Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers	Patholase, Inc.	2009	—
+3	K083215	Incisive Family of Inpulse ND:Yag Lasers	Incisive, LLC	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2001	2	0
2002	8	0
2003	3	0
2004	3	0
2005	4	0
2006	3	0
2007	1	0
2008	9	0
2009	4	0
2010	12	0
2011	13	0
2012	18	0
2013	21	0
2014	15	0
2015	15	0
2016	26	0
2017	16	0
2018	15	0
2019	11	0
2020	20	0
2021	15	0
2022	19	0
2023	20	0
2024	20	0
2025	32	0
2026	25	0

FIG. 1 — Lineage of K895518, 1989–2026Source: 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? (352)

See all 352

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

Number	Device	Applicant	Decided	Descendants
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, K980685 (Lumenis, Inc., 1998) has gone furthest, with 351 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/K895518 · printed Nov 5, 2026

Cite this page

510(k) Report. “K895518: Coherent Holmium:Yag Surgical Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K895518

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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