510(k) · Cleared

Recalled · Class II · 2016

Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo LP1RG-S, LP1RG-D

K052777510(k) TraditionalCleared Mar 16, 2006164-day reviewClass II21 CFR 878.4810Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ellex Medical Pty, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Mar 16, 2006 after a 164-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled 2 times.

Decided: Mar 16, 2006
Review: 164 days
Class: Class II
Product code: GEX
Recalls: 2
Predicates: 0

5 later devices descend from it, 3 citing it directly.

This deviceK052777 Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including…Ellex Medical Pty, Ltd. · 2006
Descendant · cites it directly · 2 of its ownK103547 Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp. · 2011
Descendant · 2 generations on · 0 of its ownK152688 LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation · 2016
Descendant · 2 generations on · 0 of its ownK124043 Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp. · 2013
Descendant · cites it directly · 0 of its ownK081565 Integre Pro, Model L2RYEllex Medical Pty, Ltd. · 2008 · Recalled
Descendant · cites it directly · 0 of its ownK080423 Integre, Model LP581Ellex Medical Pty, Ltd. · 2008

Most influential descendants

Showing 5 of 5 · See all

K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp. · 2011 · cites it directly2descendants
K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation · 2016 · 2 generations on0descendants
K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp. · 2013 · 2 generations on0descendants
K081565Integre Pro, Model L2RYEllex Medical Pty, Ltd. · 2008 · cites it directly0descendants
K080423Integre, Model LP581Ellex Medical Pty, Ltd. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K052777	Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models…	Ellex Medical Pty, Ltd.	2006	—
+1	K103547	Lightlas Multi-Wavelength Medical Laser System	Lightmed Corp.	2011	—
+2	K152688	LightLas Multi-Wavelength Medical Laser System	Lightmed Corporation	2016	—
+2	K124043	Lightlas Family of Multi-Wavelength Medical Laser System	Lightmed Corp.	2013	—
+1	K081565	Integre Pro, Model L2RY	Ellex Medical Pty, Ltd.	2008	1
+1	K080423	Integre, Model LP581	Ellex Medical Pty, Ltd.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2011	1	0
2013	1	0
2016	1	0

FIG. 1 — Lineage of K052777, 2006–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K103547	Lightlas Multi-Wavelength Medical Laser System	Lightmed Corp.	2011	2
K081565	Integre Pro, Model L2RY	Ellex Medical Pty, Ltd.	2008	0
K080423	Integre, Model LP581	Ellex Medical Pty, Ltd.	2008	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 1, 2016	Class II	Z-1270-2016	Device Design	The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
Jun 13, 2007	Not classified	Z-0287-2008	Device Design	Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K103547 (Lightmed Corp., 2011) has gone furthest, with 2 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 Laserex Duo family of dual wavelength ophthalmic lasers are intended for use in the treatment of ocular pathology. The Laserex Duo is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: - Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; - choroidal…

Read the full statement (97 words)

The Laserex Duo family of dual wavelength ophthalmic lasers are intended for use in the treatment of ocular pathology.

The Laserex Duo is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:

- Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:

- proliferative and nonproliferative diabetic retinopathy;

- choroidal neovascularization;

- branch retinal vein occlusion;

- age-related macular degeneration;

- retinal tears and detachments;

- retinopathy of prematurity;

* Iridotomy, iridectomy, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K052777 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052777: Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo LP1RG-S, LP1RG-D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052777

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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