Avulux— 510(k) DEN250026
UnknownMatap Ii, LLC
FDA 510(k) clearance DEN250026 for Avulux, Unknown on 2026-08-21. Applicant: Matap Ii, LLC. Device class: 1.
Summary
Avulux, from the applicant listed as Matap Ii, LLC, is filed under product code QEO, light attenuation lenses for migraine-associated light sensitivity. The record doesn't describe the product beyond its name and that code.
Class I, 21 CFR 882.5811. Neurology is both the classification panel and the review panel. The record lists the submission type as Direct.
The applicant filed from Aventura, Florida. The decision date came 424 calendar days after the received date (June 23, 2025 to August 21, 2026).
Clearance details
- Applicant
- Matap Ii, LLC
- Product code
- Product code QEO
- Device class
- Class 1
- Regulation
- 21 CFR 882.5811
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Aventura, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.