510(k) · Cleared
ClearedIridex 810 Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corporation · HQF Laser, Ophthalmic
Cleared on Mar 23, 2022 as substantially equivalent to K202760 (Iridex Corporation, 2020) and 2 other predicates after a 131-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Mar 23, 2022
- Review
- 131 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894841 (1989). 13 ancestors in all, the oldest K890086 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 3 generations backK960971 Oculight GLIriderm Div. · 1996
- 2 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 1 generation backK202760 Iridex 810 LaserIridex Corporation · 2020
- This deviceK213592 Iridex 810 LaserIridex Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −3 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −2 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −1 | K202760 | Iridex 810 Laser | Iridex Corporation | 2020 | — |
| 0 (this device) | K213592 | Iridex 810 Laser | Iridex Corporation | 2022 | — |
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 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K202760 | Iridex 810 LaserSummary page 5…Iridex Device C-Probe Delivery Device Predicate Device Laser Console Company: Iridex Corporation Device: Iridex 810 Laser (K202760) Delivery Device Company: Iridex Corporation Device: MicroPulse P3 Delivery Device (K202760, K16241… | 2020 |
| * | K162416 | IRIDEX Cyclo G6 Laser System, G-Probe IlluminateSummary page 5…vice: Iridex 810 Laser (K202760) Delivery Device Company: Iridex Corporation Device: MicroPulse P3 Delivery Device (K202760, K162416, K143154) 510(k) SUMMARY; K213592 (continued) Intended Use (Indications for Use) The Iride… | 2016 |
| * | K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)Summary page 5…Iridex 810 Laser (K202760) Delivery Device Company: Iridex Corporation Device: MicroPulse P3 Delivery Device (K202760, K162416, K143154) 510(k) SUMMARY; K213592 (continued) Intended Use (Indications for Use) The Iridex 810 Las… | 2015 |
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 33 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 13 ancestors has a recall.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Iridex 810 Laser 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 Iridex 810 Laser. CONDITION TREATMENT Diabetic Retinopathy Panretinal Photocoagulation (PRP); *Nonproliferative Retinopathy Focal and Grid Laser Treatments * Macular Edema * Proliferative Retinopathy Glaucoma…
Read the full statement (146 words)
The Iridex 810 Laser 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 Iridex 810 Laser.
CONDITION TREATMENT
Diabetic Retinopathy Panretinal Photocoagulation (PRP);
*Nonproliferative Retinopathy Focal and Grid Laser Treatments
* Macular Edema
* Proliferative Retinopathy
Glaucoma Laser Trabeculoplasty; Iridotomy;
* Primary Open Angle Transscleral Cyclophotocoagulation (TSCPC)
* Closed Angle
* Refractory Glaucoma (recalcitrant/uncontrolled)
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) Focal and Grid Laser Treatments
Intra-Ocular Tumors Focal and Grid Laser Treatments
* Choroidal Hemangioma
* Choroidal Melanoma
* Retinoblastoma
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/K213592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213592: Iridex 810 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213592
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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