FDA product code · Neurology
Light Attenuation Lenses For Migraine-Associated Light Sensitivity
FDA lists QEO as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 882.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2026. No recall names this code.
Light attenuation lenses for migraine-associated light sensitivity are devices that limit light incidence of specific wavelengths to the eyes and are intended to decrease the impact of light sensitivity in patients diagnosed with migraine. The lenses can be mounted on a spectacle frame, clips, or other apertures used to hold lenses. The device is intended to be adjunctive to other therapies for migraine-associated…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QEO 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 · QEO
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QEO
Too few QEO 510(k)s in any year since 2007 to give a median.
Recalls per year · QEO
No recall names QEO since 2007.
Adverse event reports per year · QEO
No MAUDE report names QEO since 2007.
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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
Planning a device in QEO? 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