510(k) · Cleared

Cleared

Coherent Novus 3000 Argon Photocoagulator

K913127510(k) TraditionalCleared Oct 8, 199185-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 Group · GEX Powered Laser Surgical Instrument

Cleared on Oct 8, 1991 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 332 later devices descend from it.

Decided: Oct 8, 1991
Review: 85 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

332 later devices descend from it, 5 citing it directly.

This deviceK913127 Coherent Novus 3000 Argon PhotocoagulatorCoherent Medical Group · 1991
Descendant · cites it directly · 296 of its ownK991258 Novus Verdi Delivery SystemsLumenis, Inc. · 1999
Descendant · 2 generations on · 225 of its ownK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled
Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Descendant · 5 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008

Showing 5 of 332 descendants. See all descendants

Descendants cleared per year

1996high 31 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 332 · See all

K991258Novus Verdi Delivery SystemsLumenis, Inc. · 1999 · cites it directly296descendants
K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · 2 generations on225descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants
K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 5 generations on192descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K913127	Coherent Novus 3000 Argon Photocoagulator	Coherent Medical Group	1991	—
+1	K991258	Novus Verdi Delivery Systems	Lumenis, Inc.	1999	—
+2	K050738	FT Fiber Optic Delivery Systems	Fibertech GmbH	2005	5
+3	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—
+4	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—
+5	K083613	Quanta System Polysurge Diode Laser Family	Quanta System Spa	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	1	0
1999	1	0
2002	4	0
2003	4	0
2004	2	0
2005	6	0
2006	5	0
2007	6	0
2008	12	0
2009	10	0
2010	12	0
2011	12	0
2012	9	0
2013	14	0
2014	13	0
2015	15	0
2016	14	0
2017	13	0
2018	12	0
2019	14	0
2020	19	0
2021	10	0
2022	31	0
2023	16	0
2024	28	0
2025	30	0
2026	17	0

FIG. 1 — Lineage of K913127, 1991–2026Source: 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? (332)

See all 332

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

Number	Device	Applicant	Decided	Descendants
K991258	Novus Verdi Delivery Systems	Lumenis, Inc.	1999	296
K960971	Oculight GL	Iriderm Div.	1996	103
K022181	Novus Varia Ophthalmic Laser and Delivery Devices with Accessories	Lumenis, Inc.	2002	65
K973470	Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in…	Lumenis, Inc.	1997	8
K081774	Solx 790 Titanium Sapphire Laser	Solx, Inc.	2008	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?

Of its descendants, K991258 (Lumenis, Inc., 1999) has gone furthest, with 296 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/K913127 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913127: Coherent Novus 3000 Argon Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913127

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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