510(k) · Cleared
ClearedIris Oculight (R) SLX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iriderm Div. · GEX Powered Laser Surgical Instrument
Cleared on Nov 15, 1991 after a 106-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 71 later devices descend from it.
- Decided
- Nov 15, 1991
- Review
- 106 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
71 later devices descend from it, 3 citing it directly.
- This deviceK913430 Iris Oculight (R) SLXIriderm Div. · 1991
- Descendant · cites it directly · 70 of its ownK013760 DC-3300 Laser Diode PhotocoagulatorNidek, Inc. · 2002
- Descendant · cites it directly · 69 of its ownK020374 Oculight SL/SLXIridex Corp · 2002
- Descendant · 2 generations on · 29 of its ownK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- Descendant · 3 generations on · 23 of its ownK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- Descendant · 4 generations on · 22 of its ownK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K013760DC-3300 Laser Diode PhotocoagulatorNidek, Inc. · 2002 · cites it directly70descendants
- K020374Oculight SL/SLXIridex Corp · 2002 · cites it directly69descendants
- K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005 · 2 generations on29descendants
- K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009 · 3 generations on23descendants
- K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913430 | Iris Oculight (R) SLX | Iriderm Div. | 1991 | — |
| +1 | K013760 | DC-3300 Laser Diode Photocoagulator | Nidek, Inc. | 2002 | — |
| +1 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| +2 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| +3 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| +4 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (71)
See all 713 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?
- Of its descendants, K013760 (Nidek, Inc., 2002) has gone furthest, with 70 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K913430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913430: Iris Oculight (R) SLX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913430
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026