De Novo · Granted
GrantedAvulux
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Matap Ii, LLC · QEO Light Attenuation Lenses For Migraine-Associated Light Sensitivity
Granted on Aug 21, 2026 as a new device type through De Novo after a 424-day review.
- Decided
- Aug 21, 2026
- Review
- 424 days
- Class
- Class I
- Product code
- QEO
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 QEO? 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?
De Novo 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QEO devicesQEO Light Attenuation Lenses For Migraine-Associated Light Sensitivity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Avulux is a precision optical filter indicated to block light at 480 nm (high blue range) and 590 nm (red/amber range), while allowing light in the remaining visible color spectrum through, to decrease the impact of light sensitivity in patients diagnosed with episodic migraine aged 12 years of age and older. The use of the Avulux should not alter the usual care therapy of patients diagnosed with episodic migraine, including medication usage
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250026 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250026: Avulux.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250026
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026