510(k) · Cleared

Cleared

Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in Combination with the Coherent Argons

K973470510(k) TraditionalCleared Dec 9, 199788-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 Dec 9, 1997 as substantially equivalent to P830054 (Coherent Medical Division, 1984) and 8 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1984. 8 later devices descend from it.

Decided: Dec 9, 1997
Review: 88 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 9

Its longest line of descent runs back 1 generation to P830054 (1984). 9 ancestors in all. 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backP830054 Neodymium: Yag Ophthalmic Laser System 9900Coherent Medical Division · 1984
This deviceK973470 Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic…Lumenis, Inc. · 1997
Descendant · cites it directly · 5 of its ownK032357 Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
Descendant · 2 generations on · 4 of its ownK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
Descendant · 3 generations on · 1 of its ownK062336 Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006
Descendant · 3 generations on · 1 of its ownK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
Descendant · cites it directly · 1 of its ownK051944 Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta…Lumenis, Inc. · 2005

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2003high 3 (2006) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all

K032357Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003 · cites it directly5descendants
K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005 · 2 generations on4descendants
K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006 · 3 generations on1descendant
K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006 · 3 generations on1descendant
K051944Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo)…Lumenis, Inc. · 2005 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P830054	Neodymium: Yag Ophthalmic Laser System 9900	Coherent Medical Division	1984	—
0 (this device)	K973470	Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser…	Lumenis, Inc.	1997	—
+1	K032357	Novus TTX Laser and Delivery Devices with Accessories	Lumenis, Inc.	2003	—
+2	K052526	Novus 3000 Laser System and Delivery Devices	Lumenis, Inc.	2005	—
+3	K062336	Optimedica Laser Indirect Ophthalmoscope	Optimedica Corporation	2006	—
+3	K061025	Accutech Endolite Probe	Accutech Medical Technologies, Inc.	2006	—
+1	K051944	Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta…	Lumenis, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1989	3	0
1990	2	0
1991	1	0
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	2	0
2006	3	0
2009	1	0
2012	1	0

FIG. 1 — Lineage of K973470, 1984–2012Source: 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? (9)

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
*	P830054	Neodymium: Yag Ophthalmic Laser System 9900 Summary page 1 …E Argon Laser Photocoagulator Primary Classification Name: Nd: YAG laser for posterior capsulotomy; and Ophthalmic laser Predicate Devices Coherent 7970 Nd:YAG Laser (P830054/513, S14, S17-S19, §22); Coherent 7901 Nd:YAG Laser (P830054/513, S14, S17-S19, §22); Nidek YC-1200 Ophthalmic YAG Laser (K8939…	Coherent Medical Division	1984	—
*	K893987	Nidek Model YC-1200 Summary page 1 …Devices Coherent 7970 Nd:YAG Laser (P830054/513, S14, S17-S19, §22); Coherent 7901 Nd:YAG Laser (P830054/513, S14, S17-S19, §22); Nidek YC-1200 Ophthalmic YAG Laser (K893987; K901481); Lasag Microruptor 2 Nd:YAG Ophthalmic (P840012, K885164); Zeiss Visulas YAG II Laser (K926452); Alcon 3000LE Nd:YAG…	Nidek, Inc.	1989	1
*	K901481	Model YC-1200/Photocoagulator Ophthalmic Laser Summary page 1 …Coherent 7970 Nd:YAG Laser (P830054/513, S14, S17-S19, §22); Coherent 7901 Nd:YAG Laser (P830054/513, S14, S17-S19, §22); Nidek YC-1200 Ophthalmic YAG Laser (K893987; K901481); Lasag Microruptor 2 Nd:YAG Ophthalmic (P840012, K885164); Zeiss Visulas YAG II Laser (K926452); Alcon 3000LE Nd:YAG Ophthalm…	Nidek, Inc.	1990	—
*	P840012	Microruptor MR-2 ND:Yag Laser System Summary page 1 …-S19, §22); Coherent 7901 Nd:YAG Laser (P830054/513, S14, S17-S19, §22); Nidek YC-1200 Ophthalmic YAG Laser (K893987; K901481); Lasag Microruptor 2 Nd:YAG Ophthalmic (P840012, K885164); Zeiss Visulas YAG II Laser (K926452); Alcon 3000LE Nd:YAG Ophthalmic Laser System (K897099); Coherent Novus 2000/ N…	Meridian AG	1986	—
*	K885164	Lasag Microruptor 2 ND:Yag Ophth. Laser System Summary page 1 …); Coherent 7901 Nd:YAG Laser (P830054/513, S14, S17-S19, §22); Nidek YC-1200 Ophthalmic YAG Laser (K893987; K901481); Lasag Microruptor 2 Nd:YAG Ophthalmic (P840012, K885164); Zeiss Visulas YAG II Laser (K926452); Alcon 3000LE Nd:YAG Ophthalmic Laser System (K897099); Coherent Novus 2000/ Nd: YAG La…	Chiron Vision Corp.	1989	—
*	K926452	Zeiss Visulas Yag II Laser Summary page 1 …/513, S14, S17-S19, §22); Nidek YC-1200 Ophthalmic YAG Laser (K893987; K901481); Lasag Microruptor 2 Nd:YAG Ophthalmic (P840012, K885164); Zeiss Visulas YAG II Laser (K926452); Alcon 3000LE Nd:YAG Ophthalmic Laser System (K897099); Coherent Novus 2000/ Nd: YAG Laser System (K893709, P830054/522); Ulti…	Carl Zeiss, Inc.	1993	—
*	K897099	Model 2800 ND:Yag Ophthalmic Laser Summary page 1 …Laser (K893987; K901481); Lasag Microruptor 2 Nd:YAG Ophthalmic (P840012, K885164); Zeiss Visulas YAG II Laser (K926452); Alcon 3000LE Nd:YAG Ophthalmic Laser System (K897099); Coherent Novus 2000/ Nd: YAG Laser System (K893709, P830054/522); Ultima 2000 and 2000SE Argon Laser Photocoagulators (K913127…	Alcon Surgical, Inc.	1990	—
*	K893709	Coherent Marie Argon Photocoagulator Summary page 1 …Ophthalmic (P840012, K885164); Zeiss Visulas YAG II Laser (K926452); Alcon 3000LE Nd:YAG Ophthalmic Laser System (K897099); Coherent Novus 2000/ Nd: YAG Laser System (K893709, P830054/522); Ultima 2000 and 2000SE Argon Laser Photocoagulators (K913127); Nidek Ophthalmic Models YC-1200/Photocoagulator Co…	Coherent Medical Group	1989	—
*	K913127	Coherent Novus 3000 Argon Photocoagulator Summary page 1 …3000LE Nd:YAG Ophthalmic Laser System (K897099); Coherent Novus 2000/ Nd: YAG Laser System (K893709, P830054/522); Ultima 2000 and 2000SE Argon Laser Photocoagulators (K913127); Nidek Ophthalmic Models YC-1200/Photocoagulator Combination Ophthalmic Laser (K901481). 510(k) Coherent Popeye Ophthalmic Las…	Coherent Medical Group	1991	—

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K032357	Novus TTX Laser and Delivery Devices with Accessories	Lumenis, Inc.	2003	5
K051944	Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo)…	Lumenis, Inc.	2005	1

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?

1 of the 9 ancestors has a recall of any class.
Of its descendants, K032357 (Lumenis, Inc., 2003) has gone furthest, with 5 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	—

What is it indicated for?

The Coherent Popeye Ophthalmic Laser is indicated for use in photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser. These indications include: discission of the posterior capsule of the eye (posterior capsulotomy) discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients The Coherent Popeye Ophthalmic Laser in Combination with the Ultima 2000 or Ultima 2000SE Argon Photocoagulator is…

Read the full statement (305 words)

The Coherent Popeye Ophthalmic Laser is indicated for use in photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser. These indications include:

discission of the posterior capsule of the eye (posterior capsulotomy)

discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients

The Coherent Popeye Ophthalmic Laser in Combination with the Ultima 2000 or Ultima 2000SE Argon Photocoagulator is indicated for:

a. Popeye Nd:YAG 1064 nm wavelength - Indicated for use in photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser. These indications include:

o discission of the posterior capsule of the eye (posterior capsulotomy) and;

e discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients.

b. Ultima 2000/Ultima 2000SE - Indicated for use in the treatment of ocular pathology using blue-green and green argon laser energy. These indications include:

e photocoagulation of both anterior and posterior segments including:

e iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma;

e retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including;

- diabetic retinopathy;

- choroidal neovascularization;

- branch retinal vein occlusion;

- subretinal neovascularization in disciform macular degeneration.

The Coherent Popeye Ophthalmic Laser in Combination with the Ultima 2000 or Ultima 2000SE Argon Photocoagulator (Indications continued)

Laser Indirect Ophthalmoscope

The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments:

o diabetic retinopathy (pan-retinal photocoagulation);

e retinopexy;

e segmental peripheral photocoagulation;

e segmental photocoagulation;

¢ cloudy vitreous cavities; and,

o pediatric retinal repairs (under general anesthesia)

Acculite Endoprobe

The Acculite Endoprobe is indicated for use in the following ophthalmic applications:

¢ photocoagulation of the anterior and posterior segment, including:

- anterior segment treatment in the surgical management of glaucoma;

- endophotocoagulation in vitreoretinal surgery - including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

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/K973470 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973470: Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in Combination with the Coherent Argons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973470

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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