510(k) · Cleared

Cleared

Nidek DC-3000 Diode Laser Photocoagulator

K903639510(k) TraditionalCleared Feb 4, 1991175-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

Nidek, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Feb 4, 1991 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 71 later devices descend from it.

Decided: Feb 4, 1991
Review: 175 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

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

This deviceK903639 Nidek DC-3000 Diode Laser PhotocoagulatorNidek, Inc. · 1991
Descendant · cites it directly · 70 of its ownK013760 DC-3300 Laser Diode PhotocoagulatorNidek, Inc. · 2002
Descendant · 2 generations on · 69 of its ownK020374 Oculight SL/SLXIridex Corp · 2002
Descendant · 3 generations on · 29 of its ownK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
Descendant · 4 generations on · 23 of its ownK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
Descendant · 5 generations on · 22 of its ownK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009

Showing 5 of 71 descendants. See all descendants

Descendants cleared per year

2002high 5 (2009) · low 0 (2021)2026

Most influential descendants

Showing 5 of 71 · See all

K013760DC-3300 Laser Diode PhotocoagulatorNidek, Inc. · 2002 · cites it directly70descendants
K020374Oculight SL/SLXIridex Corp · 2002 · 2 generations on69descendants
K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005 · 3 generations on29descendants
K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009 · 4 generations on23descendants
K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009 · 5 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K903639	Nidek DC-3000 Diode Laser Photocoagulator	Nidek, Inc.	1991	—
+1	K013760	DC-3300 Laser Diode Photocoagulator	Nidek, Inc.	2002	—
+2	K020374	Oculight SL/SLX	Iridex Corp	2002	—
+3	K043486	Pascal Photocoagulator, Product-Pascal-01	Topcon Medical Laser Systems, Inc.	2005	—
+4	K091666	Pascal Photocoagulator, Pascal-US	Optimedica Corporation	2009	—
+5	K092621	Pascal Streamline Photocoagulator	Topcon Medical Laser Systems, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	4	0
2003	3	0
2004	1	0
2005	3	0
2006	3	0
2007	2	0
2008	1	0
2009	5	0
2010	4	0
2011	3	0
2012	5	0
2013	3	0
2014	1	0
2015	4	0
2016	2	0
2017	5	0
2018	1	0
2019	5	0
2020	3	0
2022	5	0
2023	2	0
2024	4	0
2025	2	0

FIG. 1 — Lineage of K903639, 1991–2025Source: 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? (71)

See all 71

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

Number	Device	Applicant	Decided	Descendants
K013760	DC-3300 Laser Diode Photocoagulator	Nidek, Inc.	2002	70
K032357	Novus TTX Laser and Delivery Devices with Accessories	Lumenis, Inc.	2003	5

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, K013760 (Nidek, Inc., 2002) has gone furthest, with 70 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/K903639 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903639: Nidek DC-3000 Diode Laser Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903639

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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