# DEN250026: Avulux

- Pathway: De Novo (Direct)
- Applicant: Matap Ii, LLC
- Decided: Aug 21, 2026 after 424 days
- Product code: QEO (Light Attenuation Lenses For Migraine-Associated Light Sensitivity)
- Device class: 1
- Regulation: 21 CFR 882.5811
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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

Source page: https://510kreport.com/device/DEN250026
Methodology: https://510kreport.com/methodology