510(k) · Cleared
ClearedOculight SL/SLX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corp · HQF Laser, Ophthalmic
Cleared on May 3, 2002 as substantially equivalent to K894841 (Iriderm Div., 1989) and 4 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1989. 69 later devices descend from it.
- Decided
- May 3, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K894841 (1989). 8 ancestors in all, the oldest K890086 (1989). 69 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 1 generation backK960971 Oculight GLIriderm Div. · 1996
- This deviceK020374 Oculight SL/SLXIridex Corp · 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
- Descendant · cites it directly · 21 of its ownK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- Descendant · 2 generations on · 18 of its ownK062624 Next Generation LaserAlcon Laboratories · 2007
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- 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
- K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003 · cites it directly21descendants
- K062624Next Generation LaserAlcon Laboratories · 2007 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −1 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| 0 (this device) | K020374 | Oculight SL/SLX | Iridex Corp | 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 | — |
| +1 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| +2 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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), 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? (5)
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…stantially equivalent to other currently legally marketed ophthalmology laser devices including IRIDEX Corporation’s IRIS Medical OcuLight SL/SLx Laser Photocoagulators (K894841 and K913430), the IRIS Medical OcuLight GL Laser Photocoagulator (K960971), the Keeler Instruments, Microlase (K890086), and the… | 1989 |
| * | K913430 | Iris Oculight (R) SLXSummary page 1…quivalent to other currently legally marketed ophthalmology laser devices including IRIDEX Corporation’s IRIS Medical OcuLight SL/SLx Laser Photocoagulators (K894841 and K913430), the IRIS Medical OcuLight GL Laser Photocoagulator (K960971), the Keeler Instruments, Microlase (K890086), and the Nidek, DC-33… | 1991 |
| * | K960971 | Oculight GLSummary page 1…ser devices including IRIDEX Corporation’s IRIS Medical OcuLight SL/SLx Laser Photocoagulators (K894841 and K913430), the IRIS Medical OcuLight GL Laser Photocoagulator (K960971), the Keeler Instruments, Microlase (K890086), and the Nidek, DC-3300 Laser Diode Photocoagulation (K013760). Device Description… | 1996 |
| * | K890086 | Microlase 8 0 0 (Ophthalmic Laser)Summary page 1…IS Medical OcuLight SL/SLx Laser Photocoagulators (K894841 and K913430), the IRIS Medical OcuLight GL Laser Photocoagulator (K960971), the Keeler Instruments, Microlase (K890086), and the Nidek, DC-3300 Laser Diode Photocoagulation (K013760). Device Description The OcuLight SL/SLx is a semiconductor diod… | 1989 |
| * | K013760 | DC-3300 Laser Diode Photocoagulator Cleared while this submission was under review Summary page 1…K913430), the IRIS Medical OcuLight GL Laser Photocoagulator (K960971), the Keeler Instruments, Microlase (K890086), and the Nidek, DC-3300 Laser Diode Photocoagulation (K013760). Device Description The OcuLight SL/SLx is a semiconductor diode laser system that delivers pulsed infrared 810 nm laser light… | 2002 |
What descends from it? (69)
See all 699 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043486 | Pascal Photocoagulator, Product-Pascal-01 | 2005 | 29 |
| K031665 | Iris Medical Oculight GL/GLX Laser Systems | 2003 | 21 |
| K023464 | Viridis Twin Ophthalmic Photocoagulator | 2003 | 7 |
| K032357 | Novus TTX Laser and Delivery Devices with Accessories | 2003 | 5 |
| K202760 | Iridex 810 Laser | 2020 | 1 |
| K022228 | Family of Iris Medical Endoprobe Handpieces | 2002 | 1 |
| K062074 | Iridex Wireless Footswitch | 2006 | 0 |
| K040209 | Iris Medical IQ 810 Photocoagulator | 2004 | 0 |
| K023094 | Iridis Ophthalmic Photocoagulator | 2002 | 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 13 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K043486 (Topcon Medical Laser Systems, Inc., 2005) has gone furthest, with 29 descendants of its own.
- 1 other device also cites its predicate K894841.
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 IRIDEX OcuLight SL/SLx is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the OcuLight SL/SLx laser systems. Condition: Diabetic Retinopathy Treatment: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments Condition: Glaucoma Treatment: Laser Trabeculoplasty; Iridotomy…
Read the full statement (140 words)
The IRIDEX OcuLight SL/SLx is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the OcuLight SL/SLx laser systems.
Condition: Diabetic Retinopathy
Treatment: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments
Condition: Glaucoma
Treatment: Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation
Condition: Retinal Tears, Detachments, and Holes
Treatment: Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments
Condition: Lattice Degeneration
Treatment: PRP; Focal and Grid Laser Treatments
Condition: Age-related Macular Degeneration (AMD)
Treatment: Focal and Grid Laser Treatments
Condition: Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma)
Treatment: Focal and Grid Laser Treatments
Condition: Retinopathy of Prematurity
Treatment: PRP; TSRPC; Focal and Grid Laser Treatments
Condition: Sub-Retinal (choroidal) Neovascularization
Treatment: Focal and Grid Laser Treatments
Condition: Central and Branch Retinal Vein Occlusion
Treatment: PRP; Focal and Grid Laser Treatments
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/K020374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020374: Oculight SL/SLX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020374
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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