510(k) · Cleared
ClearedVisulas Yag Iii
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 9, 2004 after a 31-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Sep 9, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK042139 Visulas Yag IiiCarl Zeiss Meditec, AG · 2004
- Descendant · cites it directly · 3 of its ownK140336 Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014
- Descendant · 2 generations on · 1 of its ownK192045 Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK220430 CapsuloQuantel Medical · 2022
- Descendant · 3 generations on · 0 of its ownK203130 Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K140336Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014 · cites it directly3descendants
- K192045Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2019 · 2 generations on1descendant
- K220430CapsuloQuantel Medical · 2022 · 2 generations on0descendants
- K203130Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042139 | Visulas Yag Iii | Carl Zeiss Meditec, AG | 2004 | — |
| +1 | K140336 | Optimus Fusion: SLT, Yag and Yag/SLT | Quantel Medical | 2014 | — |
| +2 | K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2019 | — |
| +2 | K220430 | Capsulo | Quantel Medical | 2022 | — |
| +3 | K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | — | VISULAS YAG II Plus Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140336 | Optimus Fusion: SLT, Yag and Yag/SLT | 2014 | 3 |
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, K140336 (Quantel Medical, 2014) has gone furthest, with 3 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?
This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042139: Visulas Yag Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042139
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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