510(k) · Cleared
ClearedSelecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis Be, Inc. · HQF Laser, Ophthalmic
Cleared on Jul 15, 2022 as substantially equivalent to K081704 (Lumenis, Inc., 2008) after a 112-day review. Its family tree reaches back 4 generations to 1989. 2 later devices descend from it.
- Decided
- Jul 15, 2022
- Review
- 112 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894841 (1989). 14 ancestors in all, the oldest K812219 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 3 generations backK960971 Oculight GLIriderm Div. · 1996
- 2 generations backK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- 1 generation backK081704 Selecta Family of Ophithalmic Laser SystemsLumenis, Inc. · 2008
- This deviceK220877 Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser…Lumenis Be, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK230722 Eagle deviceBelkin Vision, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK252979 Voyager DSLT (430840610)Belkin Vision, Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −3 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −2 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| −1 | K081704 | Selecta Family of Ophithalmic Laser Systems | Lumenis, Inc. | 2008 | — |
| 0 (this device) | K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Be, Inc. | 2022 | — |
| +1 | K230722 | Eagle device | Belkin Vision, Ltd. | 2023 | — |
| +2 | K252979 | Voyager DSLT (430840610) | Belkin Vision, Ltd. | 2026 | — |
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 |
|---|---|---|
| 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K081704 | Selecta Family of Ophithalmic Laser SystemsSummary page 4…PREDICATE DEVICE: Selecta Duet and Trio Laser Systems Applicant: Lumenis, Inc. 510(k) Number: K081704 Classification Name: Powered Laser Surgical Instrument Device Cla… | 2008 |
| † | K151109 | Lumenis Smart532 Laser System | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230722 | Eagle device | 2023 | 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?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K230722 (Belkin Vision, Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K081704.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
* Selecta Duet LED or Digital 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), iridotomy/ iridectomy, and selective laser trabeculoplasty.
* Selecta LED Trio or Digital 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), iridotomy/ iridectomy, selective laser trabeculoplasty, and retinal photocoagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220877: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220877
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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