FDA product code · Ophthalmic
Excimer Laser System
15 FDA decisions since 1995. 24 recalls name this code, 0 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LZS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in LZS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report