510(k) · Cleared
ClearedIris Medical IQ 810 Photocoagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corp · HQF Laser, Ophthalmic
Cleared on Sep 20, 2004 as substantially equivalent to K020374 (Iridex Corp, 2002) after a 234-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Sep 20, 2004
- Review
- 234 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K894841 (1989). 9 ancestors in all, the oldest K890086 (1989). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −2 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −1 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| 0 (this device) | K040209 | Iris Medical IQ 810 Photocoagulator | Iridex Corp | 2004 | — |
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 |
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 |
|---|---|---|---|
| * | K020374 | Oculight SL/SLXSummary page 5…antially equivalent to other currently legally marketed ophthalmology laser devices including IRIDEX Corporation's IRIS Medical OcuLight SLx Laser Photocoagulator (K020374). Device Description The IQ 8 10 is a semiconductor diode laser system that delivers infrared 8 10 nm laser light intende… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 9 ancestors has a recall.
- 8 other devices also cite its predicate K020374.
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 IQ 810 is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, and other laser diode treatments. The following are examples of applications for the IQ 810. Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy): Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments Glaucoma (Primary Open Angle…
Read the full statement (140 words)
The IRIDEX IQ 810 is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, and other laser diode treatments. The following are examples of applications for the IQ 810.
Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy): Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments
Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma [recalcitrant/uncontrolled]): Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC)
Retinal Tears, Detachments, and Holes: Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments
Lattice Degeneration: PRP; Focal and Grid Laser Treatments
Age-related Macular Degeneration (AMD) with Choroidal Neovascularization (CNV): Focal and Grid Laser Treatments
Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma): Focal and Grid Laser Treatments
Retinopathy of Prematurity: PRP; TSRPC; Focal and Grid Laser Treatments
Sub-Retinal (choroidal) Neovascularization: Focal and Grid Laser Treatments
Central and Branch Retinal Vein Occlusion: PRP; Focal and Grid Laser Treatments
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040209 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040209: Iris Medical IQ 810 Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040209
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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