510(k) · Cleared
ClearedIridis Ophthalmic Photocoagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · HQF Laser, Ophthalmic
Cleared on Dec 17, 2002 as substantially equivalent to K020374 (Iridex Corp, 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Dec 17, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
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) | K023094 | Iridis Ophthalmic Photocoagulator | Quantel Medical | 2002 | — |
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? (2)
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 1…(see: 21 CFR 878.48 10). Product Code: HQF; Panel: 86 Product Code: GEX; Panel: 79 Predicate devices: Iris Medical OcuLight SL/SLx (K020374); Nidek DC-3300 (KO1 3760) The predicate lasers utilize several delivery systems, including slit lamp… | 2002 |
| * | K013760 | DC-3300 Laser Diode Photocoagulator | 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 13 years and passes through 3 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 Quantel Iridis Ophthalmic Photocoagulator is indicated for the photocoagulation or ablation of pigmented tissue within the eye. Examples include: photocoagulation of pigmented tissue within the eye, transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), limited and pan-retinal photocoagulation, transpupillary photocoagulation, endophotocoagulation, treatment…
Read the full statement (82 words)
The Quantel Iridis Ophthalmic Photocoagulator is indicated for the photocoagulation or ablation of pigmented tissue within the eye.
Examples include:
photocoagulation of pigmented tissue within the eye,
transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments),
limited and pan-retinal photocoagulation,
transpupillary photocoagulation,
endophotocoagulation,
treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients),
transpupillary photocoagulation of choriodal neovasculature, and
age-related macular degeneration (AMD) treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023094 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023094: Iridis Ophthalmic Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023094
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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