510(k) · Cleared
ClearedVitra 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · GEX Powered Laser Surgical Instrument
Cleared on Dec 5, 2019 as substantially equivalent to K122251 (Quantel Medical, 2013) after a 135-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Dec 5, 2019
- Review
- 135 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894841 (1989). 28 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 backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 3 generations backK081744 Pascal Synthesis Delivery SystemOptimedica Corporation · 2008
- 2 generations backK100678 Supra Scan Delivery SystemQuantel Medical · 2010
- 1 generation backK122251 Vitra MultispotQuantel Medical · 2013
- This deviceK191962 Vitra 2Quantel Medical · 2019
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 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −3 | K081744 | Pascal Synthesis Delivery System | Optimedica Corporation | 2008 | — |
| −2 | K100678 | Supra Scan Delivery System | Quantel Medical | 2010 | — |
| −1 | K122251 | Vitra Multispot | Quantel Medical | 2013 | — |
| 0 (this device) | K191962 | Vitra 2 | Quantel Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K122251 | Vitra MultispotSummary page 4…or Usual Name Ophthalmic Lasers Classification Name Lasers, Ophthalmic; 21 C.F.R. 878.4810 Class II Product Code: GEX Predicate Device Quantel Medical Vitra Multispot (K122251) Device Description The Vitra 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagula… | 2013 |
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 30 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 28 ancestors has a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Vitra 2 is for use in the treatment of ocular pathology of anterior and posterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including:
• Proliferative and nonproliferative diabetic retinopathy
• Choroidal neovascularization
• Branch retinal vein occlusion
• Treatment of choroidal neovascularization associated with wet Age-related macular degeneration
• Retinal tears and detachments
• Macular edema
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191962: Vitra 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191962
Report an extraction error
Are you the manufacturer?
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