QEO — Light Attenuation Lenses For Migraine-Associated Light Sensitivity Class I
FDA product code QEO covers "Light Attenuation Lenses For Migraine-Associated Light Sensitivity", a Class I medical device regulated under 21 CFR 882.5811. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QEO
- Device Class
- Class I
- Regulation Number
- 882.5811
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250026 | Matap Ii | Avulux | Aug 21, 2026 |