Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

DEN250026

Avulux

510(k) number
DEN250026
Device name
Avulux
Applicant
Matap Ii, LLC FL · US
Product code
QEO — Light Attenuation Lenses For Migraine-Associated Lig
Decision date
2026-08-21
Date received
2025-06-23
Decision
Unknown
Clearance type
Direct
Advisory committee
Neurology
Official FDA record: DEN250026
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.