510(k) · Cleared
ClearedOpto Mitra Yellow Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opto Electronica SA · HQF Laser, Ophthalmic
Cleared on Nov 3, 2011 as substantially equivalent to K071687 (Iridex Corp, 2008) and 1 other predicate after a 143-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- Nov 3, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K894841 (1989). 20 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 5 generations backK960971 Oculight GLIriderm Div. · 1996
- 4 generations backK980547 Nidek Prima Model Gyc-1500/2000Nidek, Inc. · 1998
- 3 generations backK032085 Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · Recalled
- 2 generations backK042785 Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
- 1 generation backK110228 Nidek Multicolor Laser PhotocoagulatorNidek Incorporated · 2011 · Recalled
- This deviceK111643 Opto Mitra Yellow LaserOpto Electronica SA · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −5 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −4 | K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | 1998 | — |
| −3 | K032085 | Green Laser Photocoagulator Model Gyc-1000 | Nidek, Inc. | 2003 | 3 |
| −2 | K042785 | Multi Color Laser Photocoagulator, Model MC-300 | Nidek, Inc. | 2004 | — |
| −1 | K110228 | Nidek Multicolor Laser Photocoagulator | Nidek Incorporated | 2011 | 4 |
| 0 (this device) | K111643 | Opto Mitra Yellow Laser | Opto Electronica SA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K071687 | Famili of Iridex IQ Laser SystemsSummary page 2…CFR 878.4810, Surgical Devices Regulatory Class: Class II Performance standards: 21 CFR 1040.10 4. Predicate Device Name: Inidex IQ 577, Inidex Corporation, K07 1687 Nidek Multicolor Laser Photocoagulator System MC-500, k110228 5. Product Description The Photocoagulator Opto Mitra… | 2008 |
| * | K110228 | Nidek Multicolor Laser PhotocoagulatorSummary page 2…ce standards: 21 CFR 1040.10 4. Predicate Device Name: Inidex IQ 577, Inidex Corporation, K07 1687 Nidek Multicolor Laser Photocoagulator System MC-500, k110228 5. Product Description The Photocoagulator Opto Mitra Yellow Laser is equipment capable of making human retinal photocoag… | 2011 |
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 22 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 20 ancestors have a recall of any class.
- 12 other devices also cite its predicate K071687.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Opto Mitra Yellow Laser is indicated for retinal photocoagulation. Used for the following ophthalmic medical condition end treatment:
Retinal photocoagulation, panretinal photocoagulation and intravitreal endlophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
Proliferative and nonproliferative diabetic retinopathy
Choroidal neovascularization
Branch retinal vein occlusion
The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
Retinopathy of prematurity
ridlotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111643: Opto Mitra Yellow Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111643
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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