510(k) · Cleared
ClearedFrequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag Photocoagulator (Evergreen 532)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.V. Intl. S.A. · GEX Powered Laser Surgical Instrument
Cleared on May 14, 1996 after a 71-day review. The FDA summary names its predicate without a number. 297 later devices descend from it.
- Decided
- May 14, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
297 later devices descend from it, 4 citing it directly.
- This deviceK960867 Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled…B.V. Intl. S.A. · 1996
- Descendant · cites it directly · 296 of its ownK991258 Novus Verdi Delivery SystemsLumenis, Inc. · 1999
- Descendant · 2 generations on · 225 of its ownK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled
- Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 5 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Showing 5 of 297 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 297 · See all- K991258Novus Verdi Delivery SystemsLumenis, Inc. · 1999 · cites it directly296descendants
- K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · 2 generations on225descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 5 generations on192descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960867 | Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag… | B.V. Intl. S.A. | 1996 | — |
| +1 | K991258 | Novus Verdi Delivery Systems | Lumenis, Inc. | 1999 | — |
| +2 | K050738 | FT Fiber Optic Delivery Systems | Fibertech GmbH | 2005 | 5 |
| +3 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +4 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +5 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 11 | 0 |
| 2009 | 10 | 0 |
| 2010 | 11 | 0 |
| 2011 | 11 | 0 |
| 2012 | 7 | 0 |
| 2013 | 13 | 0 |
| 2014 | 12 | 0 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 11 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 17 | 0 |
| 2021 | 10 | 0 |
| 2022 | 27 | 0 |
| 2023 | 15 | 0 |
| 2024 | 25 | 0 |
| 2025 | 29 | 0 |
| 2026 | 17 | 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? (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 |
|---|---|---|---|
| * | — | Emerald Named without a submission number | |
| * | — | NOVUS 2000 Named without a submission number |
What descends from it? (297)
See all 2974 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?
- Of its descendants, K991258 (Lumenis, Inc., 1999) has gone furthest, with 296 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Used with a slit lamp adaptor, this system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including : Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment.
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/K960867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960867: Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag Photocoagulator (Evergreen 532).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960867
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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