510(k) · Cleared
ClearedSelecta Family of Ophithalmic Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 11, 2008 as substantially equivalent to K021550 (Ellex Medical Pty, Ltd., 2002) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1989. 9 later devices descend from it.
- Decided
- Sep 11, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K894841 (1989). 13 ancestors in all, the oldest K812219 (1981). 9 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 2 generations backK960971 Oculight GLIriderm Div. · 1996
- 1 generation backK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- This deviceK081704 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 ownK140336 Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014
- Descendant · cites it directly · 2 of its ownK220877 Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser…Lumenis Be, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK230722 Eagle deviceBelkin Vision, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK192045 Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130933SolutisQuantel Medical · 2013 · cites it directly4descendants
- K140336Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014 · cites it directly3descendants
- K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsLumenis Be, Inc. · 2022 · cites it directly2descendants
- K230722Eagle deviceBelkin Vision, Ltd. · 2023 · 2 generations on1descendant
- K192045Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −2 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −1 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| 0 (this device) | K081704 | Selecta Family of Ophithalmic Laser Systems | Lumenis, Inc. | 2008 | — |
| +1 | K130933 | Solutis | Quantel Medical | 2013 | — |
| +1 | K140336 | Optimus Fusion: SLT, Yag and Yag/SLT | Quantel Medical | 2014 | — |
| +1 | K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Be, Inc. | 2022 | — |
| +2 | K230722 | Eagle device | Belkin Vision, Ltd. | 2023 | — |
| +2 | K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021550 | Lumenis Selecta DuetSummary page 1…atology 21 CFR 886.4390, Ophthalmic laser C. PREDICATE DEVICE NAMES: Trade Name(s): 1) Lumenis Selecta Duet (K021550) 2) Coherent Popeye Ophthalmic Laser System (EPIC I and EPIC IV),… | 2002 |
| Kept off the family tree | K097340 | Coherent Popeye Ophthalmic Laser System (EPIC I and EPIC IV) Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesSummary page 3…etinal photocoagulation and selective laser trabeculoplasty. The intended use has not changed from the predicate devices (K021550, K97340, K022181). F. TECHNOLOGICAL CHARACTERISTICS SUMMARY & SUBSTANTIAL EQUIVALENCE The subject device, the Selecta Famil… | 2002 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K130933 (Quantel Medical, 2013) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K021550.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 Indications for use for the Selecta Family of Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duet, LaserLink S, Selecta Duo, and Selecta Trio) and Accessories are as follows: Selecta 1064: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discussion of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and…
Read the full statement (251 words)
The Indications for use for the Selecta Family of Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duet, LaserLink S, Selecta Duo, and Selecta Trio) and Accessories are as follows:
Selecta 1064: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discussion of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy.
Selecta SLT: Selective laser trabeculoplasty.
Selecta Duet: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy and selective laser trabeculoplasty.
LaserLink S: Laser delivery system for use by an ophthalmologist in the treatment of ocular tissue. The laser delivery system is intended for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, General Intended Use section.
Selecta Duo: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy and retinal photocoagulation.
Selecta Trio: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG' laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy, retinal photocoagulation and selective laser trabeculoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081704 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081704: Selecta Family of Ophithalmic Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081704
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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