FDA product code QEO: Light Attenuation Lenses For Migraine-Associated Light Sensitivity

QEO is the FDA product code for light attenuation lenses for migraine-associated light sensitivity. It is a Class I device, regulated under 21 CFR 882.5811 and reviewed by the Neurology panel. Devices under QEO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for QEO devices

openFDA lists no recalls for product code QEO.

Frequently asked questions

What is FDA product code QEO?

QEO is the FDA product code for light attenuation lenses for migraine-associated light sensitivity. It is a Class I device, regulated under 21 CFR 882.5811 and reviewed by the Neurology panel.

What device class is QEO?

Class I, regulation 21 CFR 882.5811. Typical premarket route: 510(k) exempt.

Next steps

• Run an FDA pathway report with predicate devices for product code QEO
• Run a recall and safety report across every QEO manufacturer
• Watch product code QEO for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times