510(k) · Cleared
Recalled · 2004Visulas 532S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 14, 2001 as substantially equivalent to K925642 (Carl Zeiss, Inc., 1993) after a 30-day review. Its family tree reaches back 1 generation to 1993. 19 later devices descend from it. It has been recalled once.
- Decided
- Nov 14, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925642 (1993). 19 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK925642 Zeiss Diode-Pumped Solid State LaserCarl Zeiss, Inc. · 1993
- This deviceK013402 Visulas 532SCarl Zeiss, Inc. · 2001
- Descendant · cites it directly · 6 of its ownK043236 Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical · 2005
- Descendant · cites it directly · 4 of its ownK100035 Model Visulas 532S Laser with the Vite OptionCarl Zeiss Meditec, AG · 2010
- Descendant · cites it directly · 4 of its ownK072823 Merilas 532AMeridian AG · 2007
- Descendant · 2 generations on · 3 of its ownK091064 Navilas Laser SystemOd-Os GmbH · 2009
- Descendant · 2 generations on · 3 of its ownK070776 Supra Ophthalmic Laser PhotocoagulatorQuantel Medical · 2007
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K043236Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical · 2005 · cites it directly6descendants
- K100035Model Visulas 532S Laser with the Vite OptionCarl Zeiss Meditec, AG · 2010 · cites it directly4descendants
- K072823Merilas 532AMeridian AG · 2007 · cites it directly4descendants
- K091064Navilas Laser SystemOd-Os GmbH · 2009 · 2 generations on3descendants
- K070776Supra Ophthalmic Laser PhotocoagulatorQuantel Medical · 2007 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925642 | Zeiss Diode-Pumped Solid State Laser | Carl Zeiss, Inc. | 1993 | — |
| 0 (this device) | K013402 | Visulas 532S | Carl Zeiss, Inc. | 2001 | — |
| +1 | K043236 | Frequency Doubled ND: Yag Photocoagulator, Model Vitra | Quantel Medical | 2005 | — |
| +1 | K100035 | Model Visulas 532S Laser with the Vite Option | Carl Zeiss Meditec, AG | 2010 | — |
| +1 | K072823 | Merilas 532A | Meridian AG | 2007 | — |
| +2 | K091064 | Navilas Laser System | Od-Os GmbH | 2009 | — |
| +2 | K070776 | Supra Ophthalmic Laser Photocoagulator | Quantel Medical | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K925642 | Zeiss Diode-Pumped Solid State LaserSummary page 2…38/41 O 402 )L D UF > Device Modification The VISULAS 532s laser represents an improved version of the predicate Zeiss-Diode Pumped Solid State Laser (K925642). The improvement includes the following 2 modifications, which are detailed introduced in the Special 510(k) - Device Modificat… | 1993 |
What descends from it? (19)
See all 195 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2004 | Not classified | Z-1066-04 | Other | The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye. Retinal… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K043236 (Quantel Medical, 2005) has gone furthest, with 6 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?
The VISULAS 532s laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye.
The laser energy is delivered via either transpupillary, delivery or intraocular endoprobe delivery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013402: Visulas 532S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013402
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026