QIUClass II
Intense Pulsed Light Device For Managing Dry Eye
Ophthalmic · 21 CFR 886.5201
An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
MDR events1All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances1All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code