510(k) · Cleared
ClearedVitra 810
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · HQF Laser, Ophthalmic
Cleared on Aug 6, 2020 as substantially equivalent to K081946 (Quantel Medical, 2009) and 1 other predicate after a 62-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Aug 6, 2020
- Review
- 62 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K894841 (1989). 20 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 6 generations backK960971 Oculight GLIriderm Div. · 1996
- 5 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 4 generations backK023464 Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical · 2003
- 3 generations backK043236 Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical · 2005
- 2 generations backK070776 Supra Ophthalmic Laser PhotocoagulatorQuantel Medical · 2007
- 1 generation backK081946 Supra Twin Ophthalmic Laser PhotocoagulatorQuantel Medical · 2009
- This deviceK201502 Vitra 810Quantel Medical · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −6 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −5 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −4 | K023464 | Viridis Twin Ophthalmic Photocoagulator | Quantel Medical | 2003 | — |
| −3 | K043236 | Frequency Doubled ND: Yag Photocoagulator, Model Vitra | Quantel Medical | 2005 | — |
| −2 | K070776 | Supra Ophthalmic Laser Photocoagulator | Quantel Medical | 2007 | — |
| −1 | K081946 | Supra Twin Ophthalmic Laser Photocoagulator | Quantel Medical | 2009 | — |
| 0 (this device) | K201502 | Vitra 810 | Quantel Medical | 2020 | — |
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 |
| 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 |
|---|---|---|---|
| * | K081946 | Supra Twin Ophthalmic Laser PhotocoagulatorSummary page 4…Powered Laser Surgical Instrument; 21 C.F.R. 886.4390 Class II Product Code: HQF Primary Predicate Device Quantel Medical Supra Twin Ophthalmic Laser (K081946) Product Code: HQF Secondary Predicate Device Iridex IQ 810 (K071687) Product Code: GEX 1… | 2009 |
| * | K071687 | Famili of Iridex IQ Laser SystemsSummary page 4…ode: HQF Primary Predicate Device Quantel Medical Supra Twin Ophthalmic Laser (K081946) Product Code: HQF Secondary Predicate Device Iridex IQ 810 (K071687) Product Code: GEX 1… | 2008 |
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 31 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 20 ancestors has a recall of any class.
- 1 other device also cites its predicate K081946.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following: * Retinal photocoagulation for the treatment of: o Diabetic retinopathy including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy o Retinal Tears, Detachments and Holes o Lattice degeneration o Age-related macular degeneration (AMD) with…
Read the full statement (95 words)
The Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation,
transscleral retinal photocoagulation, iridotomy, including the following:
* Retinal photocoagulation for the treatment of:
o Diabetic retinopathy including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
o Retinal Tears, Detachments and Holes
o Lattice degeneration
o Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
o Retinopathy of prematurity
o Sub-retinal (choroidal) neovascularization
o Central and Branch Retinal Vein Occlusion
» Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation for the treatment of glaucoma, including:
o Primary open angle
o Closed angle
o Refractory Glaucoma (recalcitrant/uncontrolled)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201502: Vitra 810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201502
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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