510(k) · Cleared
ClearedSupra Twin 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 Mar 25, 2009 as substantially equivalent to K070776 (Quantel Medical, 2007) and 1 other predicate after a 260-day review. Its family tree reaches back 6 generations to 1989. 2 later devices descend from it.
- Decided
- Mar 25, 2009
- Review
- 260 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K894841 (1989). 18 ancestors in all, the oldest K812219 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 5 generations backK960971 Oculight GLIriderm Div. · 1996
- 4 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 3 generations backK023464 Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical · 2003
- 2 generations backK043236 Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical · 2005
- 1 generation backK070776 Supra Ophthalmic Laser PhotocoagulatorQuantel Medical · 2007
- This deviceK081946 Supra Twin Ophthalmic Laser PhotocoagulatorQuantel Medical · 2009
- Descendant · cites it directly · 0 of its ownK201502 Vitra 810Quantel Medical · 2020
- Descendant · cites it directly · 0 of its ownK152688 LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation · 2016
Most influential descendants
Showing 2 of 2 · See allView 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 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −3 | K023464 | Viridis Twin Ophthalmic Photocoagulator | Quantel Medical | 2003 | — |
| −2 | K043236 | Frequency Doubled ND: Yag Photocoagulator, Model Vitra | Quantel Medical | 2005 | — |
| −1 | K070776 | Supra Ophthalmic Laser Photocoagulator | Quantel Medical | 2007 | — |
| 0 (this device) | K081946 | Supra Twin Ophthalmic Laser Photocoagulator | Quantel Medical | 2009 | — |
| +1 | K201502 | Vitra 810 | Quantel Medical | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K070776 | Supra Ophthalmic Laser PhotocoagulatorSummary page 1…Trade Name: Supra Twin Common Name: Ophthalmic Laser Classification name: Laser, ophthalmic (3) Equivalent legally-marketed devices. 1. Quantel Supra (K070776) 2. Quantel Viridis Twin (K023464) (4) Description The Quantel Supra Twin is a modification of the Quantel Supra (K07… | 2007 |
| * | K023464 | Viridis Twin Ophthalmic PhotocoagulatorSummary page 1…Name: Ophthalmic Laser Classification name: Laser, ophthalmic (3) Equivalent legally-marketed devices. 1. Quantel Supra (K070776) 2. Quantel Viridis Twin (K023464) (4) Description The Quantel Supra Twin is a modification of the Quantel Supra (K070776) and the Quantel Viridis Twin… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K201502 (Quantel Medical, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Twin Ophthalmic Laser Photocoagulator wavelength 532nm 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…
Read the full statement (173 words)
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 532nm 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.
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 81 Onm is indicated for use for:
Phocoagulation or ablation 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 choroidal neovasculature, and Age related macular degeneration (AMD) treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081946 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081946: Supra Twin Ophthalmic Laser Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081946
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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