510(k) DEN250026
DEN250026 is an FDA 510(k) premarket notification submitted by Matap Ii, LLC for the device "Avulux". The FDA issued a decision of De Novo Granted on Aug 21, 2026. The device falls under product code QEO (Light Attenuation Lenses For Migraine-Associated Light Sensitivity), a Class I device regulated under 21 CFR 882.5811.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Aug 21, 2026
- Date Received
- Jun 23, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Attenuation Lenses For Migraine-Associated Light Sensitivity
- Device Class
- Class I
- Regulation Number
- 882.5811
- Review Panel
- NE
- Submission Type
Light attenuation lenses for migraine-associated light sensitivity are devices that limit light incidence of specific wavelengths to the eyes and are intended to decrease the impact of light sensitivity in patients diagnosed with migraine. The lenses can be mounted on a spectacle frame, clips, or other apertures used to hold lenses. The device is intended to be adjunctive to other therapies for migraine-associated light sensitivity. Sunglasses (nonprescription) and prescription spectacle lenses are separately classified under § 886.5850 and § 886.5844, respectively.