510(k) clearance
Avulux
- 510(k) number
- DEN250026
- Applicant
- Matap Ii, LLC
- Decision date
- Aug 21, 2026
- Date received
- Jun 23, 2025
- Decision
- Unknown
- Clearance type
- Direct
- Product code
- QEO
- Device type
- Light Attenuation Lenses For Migraine-Associated Light Sensitivity
- Device class
- Class I
- Regulation
- 21 CFR 882.5811
- Advisory committee
- Neurology
- Third party
- N
- Location
- Aventura, FL, US