510(k) · Cleared
ClearedOpto Hyalus Green Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opto Eletronica S/A · HQF Laser, Ophthalmic
Cleared on Aug 20, 2012 as substantially equivalent to K031665 (Iridex Corp, 2003) after a 452-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Aug 20, 2012
- Review
- 452 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933880 (1994). 20 ancestors in all, the oldest K883541 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 4 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 3 generations backK964074 Diolite 532Iriderm Div. · 1997
- 2 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 1 generation backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- This deviceK111460 Opto Hyalus Green LaserOpto Eletronica S/A · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −4 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −3 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −2 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −1 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| 0 (this device) | K111460 | Opto Hyalus Green Laser | Opto Eletronica S/A | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2002 | 3 | 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 |
|---|---|---|---|
| * | K031665 | Iris Medical Oculight GL/GLX Laser SystemsSummary page 2…Regulatory Class: HI Performance standards: 21 CFR 1040.10 4. Predicate Device Name: IRIS Medical OcuLight GL/GLx Laser Systems, Inidex Corporation, K03 1665 5. Product Description The Opto Hyalus Green Laser solid state, freq uency-dou bled, green Nd;YAG surgical laser system is… | 2003 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 20 ancestors has a recall of any class.
- 2 other devices also cite its predicate K031665.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Hyalus Green Laser is indicated for retinal photocoagulation. Used for
the following ophthalmic medical condition and treatment:
* Retinal photocoagulation, panretinal photocoagulation and intravitreal
endlophotocoagulation of vascular and structural abnormalities of the
retina and choroids, including:
Proliferative and non proliferative diabetic retinopathy
Choroidal neovascularization
Branch retinal vein occlusion
The treatment of choroidal neovascularization associated with
wet age related macular degeneration Retinal tears and
detachments
* Iridlotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and
open angle glaucoma
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111460 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111460: Opto Hyalus Green Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111460
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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