510(k) · Cleared
ClearedEagle device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belkin Vision, Ltd. · HQF Laser, Ophthalmic
Cleared on Dec 8, 2023 as substantially equivalent to K220877 (Lumenis Be, Inc., 2022) after a 267-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Dec 8, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894841 (1989). 15 ancestors in all, the oldest K812219 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 4 generations backK960971 Oculight GLIriderm Div. · 1996
- 3 generations backK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- 2 generations backK081704 Selecta Family of Ophithalmic Laser SystemsLumenis, Inc. · 2008
- 1 generation backK220877 Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser…Lumenis Be, Inc. · 2022
- This deviceK230722 Eagle deviceBelkin Vision, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK252979 Voyager DSLT (430840610)Belkin Vision, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252979Voyager DSLT (430840610)Belkin Vision, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −4 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −3 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| −2 | K081704 | Selecta Family of Ophithalmic Laser Systems | Lumenis, Inc. | 2008 | — |
| −1 | K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Be, Inc. | 2022 | — |
| 0 (this device) | K230722 | Eagle device | Belkin Vision, Ltd. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsSummary page 5…0 Device Classification: Class 2 Product Code: HQF III. Predicate Device and Reference Devices Predicate Device • Lumenis Selecta Duet LED (K220877) Reference Devices • Topcon PSLT for PASCAL Streamline (K171488) • OD-OS Navilas Laser System 577s (K162191)… | 2022 |
| † | K171488 | PSLT for PASCAL Streamline | 2017 |
| † | K162191 | NAVILAS Laser System | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252979 | Voyager DSLT (430840610) | 2026 | 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?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K252979 (Belkin Vision, Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The Eagle device is indicated for use in selective laser trabeculoplasty (SLT).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230722: Eagle device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230722
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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