510(k) · Cleared
ClearedViridis Twin Ophthalmic Photocoagulator
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 Jan 13, 2003 as substantially equivalent to K960867 (B.V. Intl. S.A., 1996) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1989. 7 later devices descend from it.
- Decided
- Jan 13, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K894841 (1989). 13 ancestors in all, the oldest K812219 (1981). 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 2 generations backK960971 Oculight GLIriderm Div. · 1996
- 1 generation backK020374 Oculight SL/SLXIridex Corp · 2002
- This deviceK023464 Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical · 2003
- Descendant · cites it directly · 6 of its ownK043236 Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical · 2005
- Descendant · 2 generations on · 3 of its ownK070776 Supra Ophthalmic Laser PhotocoagulatorQuantel Medical · 2007
- Descendant · cites it directly · 2 of its ownK081946 Supra Twin Ophthalmic Laser PhotocoagulatorQuantel Medical · 2009
- Descendant · 2 generations on · 1 of its ownK122251 Vitra MultispotQuantel Medical · 2013
- Descendant · 2 generations on · 0 of its ownK201502 Vitra 810Quantel Medical · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K043236Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical · 2005 · cites it directly6descendants
- K070776Supra Ophthalmic Laser PhotocoagulatorQuantel Medical · 2007 · 2 generations on3descendants
- K081946Supra Twin Ophthalmic Laser PhotocoagulatorQuantel Medical · 2009 · cites it directly2descendants
- K122251Vitra MultispotQuantel Medical · 2013 · 2 generations on1descendant
- K201502Vitra 810Quantel Medical · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −2 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −1 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| 0 (this device) | K023464 | Viridis Twin Ophthalmic Photocoagulator | Quantel Medical | 2003 | — |
| +1 | 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 | — |
| +2 | K122251 | Vitra Multispot | Quantel Medical | 2013 | — |
| +2 | 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 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 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? (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…ical instrument (see: 21 CFR 878.4810). Product Code: HQF; Panel: 86 Product Code: GEX; Panel: 79 Predicate devices: Viridis Laser (K960867); Novus Verdi Delivery Systems (K99 1258) -and the Viridis laser IRIS Medic… | 1996 |
| * | K991258 | Novus Verdi Delivery SystemsSummary page 1…Product Code: HQF; Panel: 86 Product Code: GEX; Panel: 79 Predicate devices: Viridis Laser (K960867); Novus Verdi Delivery Systems (K99 1258) -and the Viridis laser IRIS Medical OcuLight SL/SLx (K020374); Nidek DC-33… | 1999 |
| * | K020374 | Oculight SL/SLXSummary page 2…ridis Laser (K960867); Novus Verdi Delivery Systems (K99 1258) -and the Viridis laser IRIS Medical OcuLight SL/SLx (K020374); Nidek DC-3300 (KO13760) The predicate lasers utilize several delivery systems, including slit lamp adapters,… | 2002 |
| * | K013760 | DC-3300 Laser Diode Photocoagulator | 2002 |
What descends from it? (7)
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 14 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K043236 (Quantel Medical, 2005) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K960867.
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?
The Viridis Twin laser is indicated for the photocoagulation or ablation of pigmented tissue within the eye. The 532 nm wavelength is indicated for use for: retinal photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. peripheral photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. endophotocoagulation (EPCP) intraocular photocoagulation as an adjunct in vitrectomy…
Read the full statement (145 words)
The Viridis Twin laser is indicated for the photocoagulation or ablation of pigmented tissue within the eye.
The 532 nm wavelength is indicated for use for:
retinal photocoagulation
proliferative diabetic retinopathy,
macular degeneration, and
retinal detachment.
peripheral photocoagulation
proliferative diabetic retinopathy,
macular degeneration, and
retinal detachment.
endophotocoagulation (EPCP)
intraocular photocoagulation as an adjunct in vitrectomy surgery,
complicated rhegmatogeous,
tractional retinal detachments,
proliferative vitreoretinopathy,
proliferative diabetic retinopathy,
retinopathy, and
retinal vascular tumors.
The 8 10 nm wavelength is indicated for use for:
photocoagulation 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 choriodal neovasculature, and
age-related macular degeneration (AMD) treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023464: Viridis Twin Ophthalmic Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023464
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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