510(k) · Cleared

Cleared

Lumenis Selecta Duet

K021550510(k) TraditionalCleared Aug 9, 200288-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

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

Cleared on Aug 9, 2002 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 16 later devices descend from it.

Decided: Aug 9, 2002
Review: 88 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

16 later devices descend from it, 6 citing it directly.

This deviceK021550 Lumenis Selecta DuetEllex Medical Pty, Ltd. · 2002
Descendant · cites it directly · 9 of its ownK081704 Selecta Family of Ophithalmic Laser SystemsLumenis, Inc. · 2008
Descendant · cites it directly · 4 of its ownK130933 SolutisQuantel Medical · 2013
Descendant · cites it directly · 3 of its ownK212630 Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloEllex Medical Pty, Ltd. · 2021
Descendant · 2 generations on · 3 of its ownK140336 Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014
Descendant · 2 generations on · 2 of its ownK220877 Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser…Lumenis Be, Inc. · 2022

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2005high 3 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 16 · See all

K081704Selecta Family of Ophithalmic Laser SystemsLumenis, Inc. · 2008 · cites it directly9descendants
K130933SolutisQuantel Medical · 2013 · cites it directly4descendants
K212630Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloEllex Medical Pty, Ltd. · 2021 · cites it directly3descendants
K140336Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014 · 2 generations on3descendants
K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsLumenis Be, Inc. · 2022 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021550	Lumenis Selecta Duet	Ellex Medical Pty, Ltd.	2002	—
+1	K081704	Selecta Family of Ophithalmic Laser Systems	Lumenis, Inc.	2008	—
+1	K130933	Solutis	Quantel Medical	2013	—
+1	K212630	Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo	Ellex Medical Pty, Ltd.	2021	—
+2	K140336	Optimus Fusion: SLT, Yag and Yag/SLT	Quantel Medical	2014	—
+2	K220877	Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems	Lumenis Be, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2008	1	0
2009	1	0
2013	1	0
2014	1	0
2019	1	0
2020	1	0
2021	1	0
2022	3	0
2023	2	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K021550, 2002–2026Source: 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? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K081704	Selecta Family of Ophithalmic Laser Systems	Lumenis, Inc.	2008	9
K130933	Solutis	Quantel Medical	2013	4
K212630	Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo	Ellex Medical Pty, Ltd.	2021	3
K051944	Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo)…	Lumenis, Inc.	2005	1
K203130	Ophthalmic Yag Laser System YC-200	Nidek Co., Ltd.	2020	0
K090774	Lightlas Selector	Lightmed Corp.	2009	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, K081704 (Lumenis, Inc., 2008) has gone furthest, with 9 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?

POSTERIOR CAPSULOTOMY

TRIDOTOMY / IRIDECTOMY

POSTERIOR MEMBRANECTOMY

SELECTIVE LASER TRABELULOPLASTY (SLT)

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

https://510kreport.com/device/K021550 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021550: Lumenis Selecta Duet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021550

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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