510(k) · Cleared
ClearedSupra Ophthalmic Laser 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 Apr 24, 2007 as substantially equivalent to K043236 (Quantel Medical, 2005) after a 34-day review. Its family tree reaches back 5 generations to 1989. 3 later devices descend from it.
- Decided
- Apr 24, 2007
- Review
- 34 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894841 (1989). 17 ancestors in all, the oldest K812219 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 4 generations backK960971 Oculight GLIriderm Div. · 1996
- 3 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 2 generations backK023464 Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical · 2003
- 1 generation backK043236 Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical · 2005
- This deviceK070776 Supra Ophthalmic Laser PhotocoagulatorQuantel Medical · 2007
- Descendant · cites it directly · 2 of its ownK081946 Supra Twin Ophthalmic Laser PhotocoagulatorQuantel Medical · 2009
- Descendant · 2 generations on · 0 of its ownK201502 Vitra 810Quantel Medical · 2020
- Descendant · 2 generations on · 0 of its ownK152688 LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −4 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −3 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −2 | K023464 | Viridis Twin Ophthalmic Photocoagulator | Quantel Medical | 2003 | — |
| −1 | K043236 | Frequency Doubled ND: Yag Photocoagulator, Model Vitra | Quantel Medical | 2005 | — |
| 0 (this device) | K070776 | Supra Ophthalmic Laser Photocoagulator | Quantel Medical | 2007 | — |
| +1 | K081946 | Supra Twin Ophthalmic Laser Photocoagulator | Quantel Medical | 2009 | — |
| +2 | K201502 | Vitra 810 | Quantel Medical | 2020 | — |
| +2 | K152688 | LightLas Multi-Wavelength Medical Laser System | Lightmed Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K043236 | Frequency Doubled ND: Yag Photocoagulator, Model VitraSummary page 1…ame: Laser, ophthalmic Product Code: HQF Regulation: 886.4390 Classification: Class 1I. (3) Equivalent legally-marketed devices. 1. Quantel VITRA, K043236 (4) Description The Quantel Supra is a modification of the Quantel Vitra, (K043236). The S… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081946 | Supra Twin Ophthalmic Laser Photocoagulator | 2009 | 2 |
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 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K081946 (Quantel Medical, 2009) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K043236.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Supra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions: With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments. With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous…
Read the full statement (91 words)
The Supra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions:
With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.
With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy.
With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070776: Supra Ophthalmic Laser Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070776
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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