510(k) · Cleared
ClearedVisulas Trion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · GEX Powered Laser Surgical Instrument
Cleared on Sep 21, 2007 as substantially equivalent to K013402 (Carl Zeiss, Inc., 2001) and 2 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Sep 21, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K894841 (1989). 20 ancestors in all, the oldest K812219 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 4 generations backK960971 Oculight GLIriderm Div. · 1996
- 3 generations backK980547 Nidek Prima Model Gyc-1500/2000Nidek, Inc. · 1998
- 2 generations backK032085 Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · Recalled
- 1 generation backK042785 Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
- This deviceK072514 Visulas TrionCarl Zeiss Meditec, AG · 2007
- Descendant · cites it directly · 0 of its ownK103056 Visulas Trion Laser System with the Vite OptionCarl Zeiss Meditec, AG · 2011
Most influential descendants
Showing 1 of 1 · See all- K103056Visulas Trion Laser System with the Vite OptionCarl Zeiss Meditec, AG · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −4 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −3 | K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | 1998 | — |
| −2 | K032085 | Green Laser Photocoagulator Model Gyc-1000 | Nidek, Inc. | 2003 | 3 |
| −1 | K042785 | Multi Color Laser Photocoagulator, Model MC-300 | Nidek, Inc. | 2004 | — |
| 0 (this device) | K072514 | Visulas Trion | Carl Zeiss Meditec, AG | 2007 | — |
| +1 | K103056 | Visulas Trion Laser System with the Vite Option | Carl Zeiss Meditec, AG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K013402 | Visulas 532SSummary page 1…Code: GEX Trade/Proprietary name: VISULAS Trion PREDICATE DEVICE Company: Carl Zeiss Meditec AG Device: VISULAS 532s (K013402) Company: Lumenis Device: Novus® VariaTM Ophthalmic Laser and Delivery Devices… | 2001 |
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesSummary page 1…VISULAS 532s (K013402) Company: Lumenis Device: Novus® VariaTM Ophthalmic Laser and Delivery Devices (K022181) Company: Nidek Device: Multi Color Laser Photocoagulator Model MC-300… | 2002 |
| * | K042785 | Multi Color Laser Photocoagulator, Model MC-300Summary page 1…(K022181) Company: Nidek Device: Multi Color Laser Photocoagulator Model MC-300 (K042785) 00018 SECTION 5.… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103056 | Visulas Trion Laser System with the Vite Option | 2011 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K103056 (Carl Zeiss Meditec, AG, 2011) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K013402.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 VISULAS Trion is intended for use in photocoagulating ocular tissues for the treatment of diseases of the eye, such as:
Photocoagulation of the retina
Trabeculoplasty for treatment of glaucoma
Iridotomy for treatment of glaucoma.
The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072514: Visulas Trion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072514
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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