Light Attenuation Lenses For Migraine-Associated Light Sensitivity
QEO is the FDA product code for Light Attenuation Lenses For Migraine-Associated Light Sensitivity, a class I device type, regulated under 21 CFR 882.5811. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QEO
- Device name
- Light Attenuation Lenses For Migraine-Associated Light Sensitivity
- FDA 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.
- Regulation
- 21 CFR 882.5811
- Device class
- Class I
- Review panel
- Neurology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QEO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code QEO| Applicant | Clearances |
|---|---|
| Matap Ii, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QEO.
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