510(k) · Cleared

Cleared

Nidek Multi Color Laser Photocoagulator, Model MC-7000

K974732510(k) TraditionalCleared Mar 18, 199890-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 Mar 18, 1998 as substantially equivalent to K932468 (Coherent Medical Group, 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1993.

Decided: Mar 18, 1998
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K930543 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK930543 E-25 Krypton Ion Laser (Surgica K5)Hgm, Inc. · 1993
This deviceK974732 Nidek Multi Color Laser Photocoagulator, Model MC-7000Nidek, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K930543	E-25 Krypton Ion Laser (Surgica K5)	Hgm, Inc.	1993	—
0 (this device)	K974732	Nidek Multi Color Laser Photocoagulator, Model MC-7000	Nidek, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

FIG. 1 — Lineage of K974732, 1993–1998Source: 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

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What was it cleared against? (2)

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
*	K932468	Novus Multiwavelength Summary page 1 …espondent: Ken Kato, VP Phone: 510-226-5700 Fax: 510-226-5750 2. Device Name Nidek MC-7000 Photo coagulator 3. Predicate Devices Coherent Novus Omni made by Coherent (K932468) HGM Spectrum K5 made by HGM (K930543) 4. Intended Use Laser beam generated by MC-7000 is to be used for photocoagulation in oph…	Coherent Medical Group	1993	—
*	K930543	E-25 Krypton Ion Laser (Surgica K5) Summary page 1 …6-5700 Fax: 510-226-5750 2. Device Name Nidek MC-7000 Photo coagulator 3. Predicate Devices Coherent Novus Omni made by Coherent (K932468) HGM Spectrum K5 made by HGM (K930543) 4. Intended Use Laser beam generated by MC-7000 is to be used for photocoagulation in ophthalmic indications in transpupillary…	Hgm, Inc.	1993	—

Also cleared against K932468: 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?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K932468.

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	—

What is it indicated for?

Delivery of Laser therapeutic radiation is accomplished by two basic means: Transpupillary: 1) Via an optical system attached to a viewing microscope either a slit-lamp or operating microscope. Retinal therapy is further aided by the use of an auxiliary viewing lenses, typically a fundus laser lens, or a wide field examination lens with a laser anti-reflection coating. Anterior segment therapy is further aided by viewing lenses which can reflect the…

Read the full statement (223 words)

Delivery of Laser therapeutic radiation is accomplished by two basic means:

Transpupillary:

1) Via an optical system attached to a viewing microscope either a slit-lamp or operating microscope.

Retinal therapy is further aided by the use of an auxiliary viewing lenses, typically a fundus laser lens, or a wide field examination lens with a laser anti-reflection coating.

Anterior segment therapy is further aided by viewing lenses which can reflect the treatment beam into the chamber angle, either with or without magnification. The lens is treated on the distal surface with a laser anti-reflection coating.

2) Via an optical system attached to an indirect ophthalmoscope either binocular or monocular, with or without auxiliary viewing lenses. Typically a +20 Diopter examination lens with a laser anti-reflection coating is employed.

Inter Operative methods:

1) Via direct radiation administered from a fiber optic cable handpiece which is inserted through an incision and positioned proximal to a point of treatment within the eye. According to the area to be treated, the fiber handpiece be formed in either a straight or curved manner.

Transpupillary laser therapy is commonly employed for the following indications:

Retinal Photocoagulation, either limited or Pan-Retinal

Macular Photocoagulation

Trabeculoplasty for Open Angle Glaucoma

Iridotomy for Acute Angle Closure Glaucoma

Inter-Operative laser therapy is employed for the following indications:

Retinal Photocoagulation, either limited or Pan-Retinal

Macular Photocoagulation

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974732 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974732: Nidek Multi Color Laser Photocoagulator, Model MC-7000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974732

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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