510(k) · Cleared
ClearedOculight GL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iriderm Div. · HQF Laser, Ophthalmic
Cleared on Aug 28, 1996 as substantially equivalent to K894841 (Iriderm Div., 1989) and 2 other predicates after a 170-day review. Its family tree reaches back 1 generation to 1989. 103 later devices descend from it.
- Decided
- Aug 28, 1996
- Review
- 170 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K894841 (1989). 3 ancestors in all. 103 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- This deviceK960971 Oculight GLIriderm Div. · 1996
- Descendant · cites it directly · 69 of its ownK020374 Oculight SL/SLXIridex Corp · 2002
- Descendant · cites it directly · 65 of its ownK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- Descendant · cites it directly · 29 of its ownK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- Descendant · 2 generations on · 23 of its ownK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- Descendant · 3 generations on · 22 of its ownK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K020374Oculight SL/SLXIridex Corp · 2002 · cites it directly69descendants
- K022181Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002 · cites it directly65descendants
- K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005 · cites it directly29descendants
- K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009 · 2 generations on23descendants
- K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| 0 (this device) | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| +1 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| +1 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| +1 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| +2 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| +3 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K894841 | Iris Oculight (TM) SLSummary page 1…tor system is substantially equivalent to other currently legally marketed laser photocoagulator devices including IRIS Medical OcuLight SL Laser Photocoagulator System (K894841), the Coherent Novus 2000® Laser Photocoagulator system (K913127); the Alcon Ophthalas® 532 Laser Photocoagulator System (K932062… | 1989 |
| * | K913127 | Coherent Novus 3000 Argon PhotocoagulatorSummary page 1…marketed laser photocoagulator devices including IRIS Medical OcuLight SL Laser Photocoagulator System (K894841), the Coherent Novus 2000® Laser Photocoagulator system (K913127); the Alcon Ophthalas® 532 Laser Photocoagulator System (K932062). Page 1 Intended Use The intended use of this… | 1991 |
| * | K932062 | Ophthalas 532 Solid State PhotocoagulatorSummary page 1…uLight SL Laser Photocoagulator System (K894841), the Coherent Novus 2000® Laser Photocoagulator system (K913127); the Alcon Ophthalas® 532 Laser Photocoagulator System (K932062). Page 1 Intended Use The intended use of this device is retinal photocoagulation and laser trabeculoplasty to… | 1994 |
What descends from it? (103)
See all 1035 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?
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960971: Oculight GL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960971
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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