PMA · Approved
Recalled · 2007Ladarvision Excimer Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · LZS Excimer Laser System
Approved on Nov 2, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 423-day review. It has been recalled 2 times.
- Decided
- Nov 2, 1998
- Review
- 423 days
- Class
- Class III
- Product code
- LZS
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P970043 has 23 supplements since 1999: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1999 | 4 |
| 2000 | 5 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 6 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2007 | Not classified | Z-0854-2007 | Other | Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser. (On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea… |
| Aug 1, 2005 | Not classified | Z-1147-06 | Other | Alcon has identified a software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LZS devicesLZS Excimer Laser System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZS
Too few LZS 510(k)s in any year since 2007 to give a median.
Recalls per year · LZS
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZS
260in 2025
MAUDE reports naming product code LZS, 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 | — | 3 | 516 |
| 2008 | 6 | — | 1 | 588 |
| 2009 | 3 | — | 0 | 266 |
| 2010 | 3 | — | 1 | 698 |
| 2011 | 6 | — | 11 | 463 |
| 2012 | 6 | — | 1 | 477 |
| 2013 | 14 | — | 4 | 944 |
| 2014 | 18 | — | 0 | 1,803 |
| 2015 | 14 | — | 0 | 1,146 |
| 2016 | 4 | — | 0 | 808 |
| 2017 | 10 | — | 0 | 1,360 |
| 2018 | 11 | — | 0 | 1,601 |
| 2019 | 13 | — | 0 | 1,063 |
| 2020 | 6 | — | 0 | 565 |
| 2021 | 7 | — | 1 | 266 |
| 2022 | 0 | — | 0 | 152 |
| 2023 | 8 | — | 0 | 128 |
| 2024 | 10 | — | 0 | 91 |
| 2025 | 6 | — | 0 | 260 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P970043 · printed Nov 6, 2026
Cite this page
510(k) Report. “P970043: Ladarvision Excimer Laser System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P970043
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026