De Novo DEN250026

Device
Avulux
Contact
charles posternack
De Novo number
DEN250026
Product code
QEO
Regulation
882.5811
Classification name
light attenuation lenses for migraine-associated light sensitivity
Decision
granted (DENG)
Decision date
2026-08-21
Date received
2025-06-23
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct