Product code QEO— Neurology
Avulux
- Classification name
- Light Attenuation Lenses For Migraine-Associated Light Sensitivity
- Device class
- Class 1
- Regulation
- 21 CFR 882.5811
- Advisory panel
- Neurology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code QEO
FDA has cleared device under product code QEO, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code QEO
Recent clearances under product code QEO
Data sourced from openFDA. This site is unofficial and independent of the FDA.