510(k) · Cleared
ClearedVisulas Trion Laser System with the Vite Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · HQF Laser, Ophthalmic
Cleared on Feb 1, 2011 as substantially equivalent to K072514 (Carl Zeiss Meditec, AG, 2007) and 5 other predicates after a 109-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Feb 1, 2011
- Review
- 109 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K894841 (1989). 34 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 backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 2 generations backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- 1 generation backK100035 Model Visulas 532S Laser with the Vite OptionCarl Zeiss Meditec, AG · 2010
- This deviceK103056 Visulas Trion Laser System with the Vite OptionCarl Zeiss Meditec, AG · 2011
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 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −2 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| −1 | K100035 | Model Visulas 532S Laser with the Vite Option | Carl Zeiss Meditec, AG | 2010 | — |
| 0 (this device) | 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 |
| 1985 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (6)
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 |
|---|---|---|---|
| * | K072514 | Visulas TrionSummary page 2…l laser intended for use in the photocoagulation of ocular tissues in treatment of diseases of the eye. Similar to the predicate device, the VISULAS Trion Laser System (K0725 14) laser, energy for the proposed device is delivered via transpupillary delivery or intraocular endoprobe delivery. The VISULAS T… | 2007 |
| * | K100035 | Model Visulas 532S Laser with the Vite OptionSummary page 2…i-spot treatment cascade delivery option. The modified LSL is identical to the LSL offered with the predicate device, the VISULAS 532s Laser System with the VITE option (K100035), also manufactured by Carl Zeiss Meditec. 4.5 STATEMENT OF INTENDED USE The VISULAS Trion Laser System is intended for use in s… | 2010 |
| * | K043486 | Pascal Photocoagulator, Product-Pascal-01Summary page 2…LAS 532 Laser System with the VITE option Carl Zeiss Meditec K(100035 March 17, 20 10 K043486, March 3, 2005, PASCAL Photocoagulator Optiedica K08 1744, September 9, 2008,… | 2005 |
| * | K081744 | Pascal Synthesis Delivery SystemSummary page 2…arch 17, 20 10 K043486, March 3, 2005, PASCAL Photocoagulator Optiedica K08 1744, September 9, 2008, Corporation K(091666, July 15, 2009,… | 2008 |
| * | K091666 | Pascal Photocoagulator, Pascal-USSummary page 3…ates the same Laser Slit Lamp (LSL) that offers the same multi-spot treatment cascade functionality as the proposed device. The Pascal Photocoagulator (K043486, K081744, K091666, K092621) achieves similar multi- spot delivery in the same manner as both the proposed and predicate VISULAS Trion and VISULAS 5… | 2009 |
| * | K092621 | Pascal Streamline PhotocoagulatorSummary page 2…K08 1744, September 9, 2008, Corporation K(091666, July 15, 2009, ___________________K092621 September 25, 2009 4.4 DEVICE DESCRIPTION The VISULAS Trion Laser System with the VIT… | 2009 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 34 ancestors have a recall of any class.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation of 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 VISULAS Trion Laser System with the VITE option is intended for use in multi-spot retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of…
Read the full statement (100 words)
The VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation of 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 VISULAS Trion Laser System with the VITE option is intended for use in multi-spot retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:
Proliferative and nonproliferative diabetic retinopathy
Macular edema
Branch and central retinal vein occlusion
Lattice degeneration
Retinal tears and detachments
Choroidal neovascularization associated with wet age-related macular degeneration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103056: Visulas Trion Laser System with the Vite Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103056
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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