FDA product code · Ophthalmic
Femtosecond Laser System For Refractive Correction
1 FDA decision since 2016. 1 recall names this code; it is not Class I.
Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OTL 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 · OTL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OTL
Too few OTL 510(k)s in any year since 2007 to give a median.
Recalls per year · OTL
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTL
9in 2025
MAUDE reports naming product code OTL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 2 | — | 1 | 8 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 3 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 5 | — | 0 | 11 |
| 2025 | 3 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
Planning a device in OTL? 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