510(k) · Cleared
ClearedFrequency Doubled ND: Yag Photocoagulator, Model Vitra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · HQF Laser, Ophthalmic
Cleared on Feb 7, 2005 as substantially equivalent to K960867 (B.V. Intl. S.A., 1996) and 3 other predicates after a 77-day review. Its family tree reaches back 4 generations to 1989. 6 later devices descend from it.
- Decided
- Feb 7, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K894841 (1989). 16 ancestors in all, the oldest K812219 (1981). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 3 generations backK960971 Oculight GLIriderm Div. · 1996
- 2 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 1 generation backK023464 Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical · 2003
- This deviceK043236 Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical · 2005
- Descendant · cites it directly · 3 of its ownK070776 Supra Ophthalmic Laser PhotocoagulatorQuantel Medical · 2007
- Descendant · 2 generations on · 2 of its ownK081946 Supra Twin Ophthalmic Laser PhotocoagulatorQuantel Medical · 2009
- Descendant · cites it directly · 1 of its ownK122251 Vitra MultispotQuantel Medical · 2013
- Descendant · 3 generations on · 0 of its ownK201502 Vitra 810Quantel Medical · 2020
- Descendant · 2 generations on · 0 of its ownK191962 Vitra 2Quantel Medical · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K070776Supra Ophthalmic Laser PhotocoagulatorQuantel Medical · 2007 · cites it directly3descendants
- K081946Supra Twin Ophthalmic Laser PhotocoagulatorQuantel Medical · 2009 · 2 generations on2descendants
- K122251Vitra MultispotQuantel Medical · 2013 · cites it directly1descendant
- K201502Vitra 810Quantel Medical · 2020 · 3 generations on0descendants
- K191962Vitra 2Quantel Medical · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −3 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −2 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −1 | K023464 | Viridis Twin Ophthalmic Photocoagulator | Quantel Medical | 2003 | — |
| 0 (this device) | K043236 | Frequency Doubled ND: Yag Photocoagulator, Model Vitra | Quantel Medical | 2005 | — |
| +1 | K070776 | Supra Ophthalmic Laser Photocoagulator | Quantel Medical | 2007 | — |
| +2 | K081946 | Supra Twin Ophthalmic Laser Photocoagulator | Quantel Medical | 2009 | — |
| +1 | K122251 | Vitra Multispot | Quantel Medical | 2013 | — |
| +3 | K201502 | Vitra 810 | Quantel Medical | 2020 | — |
| +2 | K191962 | Vitra 2 | Quantel Medical | 2019 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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? (4)
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 |
|---|---|---|---|
| * | K960867 | Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag…Summary page 1…ubled Nd:YAG (53 2 nm) laser Classification Ophthalmic laser (see 21 CFR 886.4390) Name: Product Code: HQF; Panel: 86 Predicate devices: B.V.I. Viridis Laser (K960867); Novus Verdi Laser and Delivery Systems (K99 1258), Carl Zeiss Visulas 532s (KO 13402), and the 532 nm… | 1996 |
| * | K991258 | Novus Verdi Delivery SystemsSummary page 1…e 21 CFR 886.4390) Name: Product Code: HQF; Panel: 86 Predicate devices: B.V.I. Viridis Laser (K960867); Novus Verdi Laser and Delivery Systems (K99 1258), Carl Zeiss Visulas 532s (KO 13402), and the 532 nm laser of the Quantel Viridis Twin Laser (K023464). Devic… | 1999 |
| * | K013402 | Visulas 532S | 2001 |
| * | K023464 | Viridis Twin Ophthalmic PhotocoagulatorSummary page 1…Laser and Delivery Systems (K99 1258), Carl Zeiss Visulas 532s (KO 13402), and the 532 nm laser of the Quantel Viridis Twin Laser (K023464). Device description: The Quantel Vitra Ophthalmic Laser Photocoagulator is a Nd:YAG frequency doubled laser… | 2003 |
What descends from it? (6)
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 16 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K070776 (Quantel Medical, 2007) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K960867.
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 Vitra 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 Vitra 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/K043236 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043236: Frequency Doubled ND: Yag Photocoagulator, Model Vitra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043236
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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