510(k) · Cleared
ClearedModel Visulas 532S Laser 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 · GEX Powered Laser Surgical Instrument
Cleared on Mar 17, 2010 as substantially equivalent to K013402 (Carl Zeiss, Inc., 2001) and 4 other predicates after a 70-day review. Its family tree reaches back 6 generations to 1989. 4 later devices descend from it.
- Decided
- Mar 17, 2010
- Review
- 70 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K894841 (1989). 26 ancestors in all, the oldest K812219 (1981). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 5 generations backK960971 Oculight GLIriderm Div. · 1996
- 4 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 3 generations backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 2 generations backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 1 generation backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- This deviceK100035 Model Visulas 532S Laser with the Vite OptionCarl Zeiss Meditec, AG · 2010
- Descendant · cites it directly · 2 of its ownK181682 VISULAS greenCarl Zeiss Meditec, AG · 2019
- Descendant · 2 generations on · 1 of its ownK232051 VISULAS greenCarl Zeiss Meditec · 2023
- Descendant · 3 generations on · 0 of its ownK233911 VISULAS combiCarl Zeiss Meditec, AG · 2024
- Descendant · cites it directly · 0 of its ownK103056 Visulas Trion Laser System with the Vite OptionCarl Zeiss Meditec, AG · 2011
Most influential descendants
Showing 4 of 4 · See all- K181682VISULAS greenCarl Zeiss Meditec, AG · 2019 · cites it directly2descendants
- K232051VISULAS greenCarl Zeiss Meditec · 2023 · 2 generations on1descendant
- K233911VISULAS combiCarl Zeiss Meditec, AG · 2024 · 3 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −6 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −5 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −4 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −3 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −2 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −1 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| 0 (this device) | K100035 | Model Visulas 532S Laser with the Vite Option | Carl Zeiss Meditec, AG | 2010 | — |
| +1 | K181682 | VISULAS green | Carl Zeiss Meditec, AG | 2019 | — |
| +2 | K232051 | VISULAS green | Carl Zeiss Meditec | 2023 | — |
| +3 | K233911 | VISULAS combi | Carl Zeiss Meditec, AG | 2024 | — |
| +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 |
| 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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (5)
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 2…== PREDICATE DEVICES PRED MANUFACT~~~URER CLAANE CLEARNEDT VISULAS 532s Carl Zeiss Meditec AG K013402 November 14, 2001 PASCAL Photocoagulator OptiMedica Corporation K043486 March 3, 2005… | 2001 |
| * | K043486 | Pascal Photocoagulator, Product-Pascal-01Summary page 2…EDT VISULAS 532s Carl Zeiss Meditec AG K013402 November 14, 2001 PASCAL Photocoagulator OptiMedica Corporation K043486 March 3, 2005 PASCAL Symnthesis OptiMedica Corporation K08 1744 September 9, 2008 Deliver… | 2005 |
| * | K081744 | Pascal Synthesis Delivery SystemSummary page 2…2001 PASCAL Photocoagulator OptiMedica Corporation K043486 March 3, 2005 PASCAL Symnthesis OptiMedica Corporation K08 1744 September 9, 2008 Delivery System PhotCoAgLao OptiMedica Corporation K091966 July… | 2008 |
| * | K091666 | Pascal Photocoagulator, Pascal-US Our reading of the summary gave K091966, FDA’s number for Angiosculpt Pta Scoring Balloon Catheter, Models… (Angioscore, Inc.). Corrected to the number one digit away that FDA lists under the company the summary names beside it. | 2009 |
| * | K092621 | Pascal Streamline PhotocoagulatorSummary page 2…Delivery System PhotCoAgLao OptiMedica Corporation K091966 July 15, 2009 PASCAL Streamline OptiMedica Corporation K092621 September 25, 2009 Photocoagulator DEVICE DESCRIPTION The VISULAS 532s Laser System with the VITE option is an ophth… | 2009 |
What descends from it? (4)
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 21 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K181682 (Carl Zeiss Meditec, AG, 2019) has gone furthest, with 2 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. 2010, 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 532s Laser System with the VITE option is intended for use in 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100035: Model Visulas 532S Laser 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/K100035
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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