QIU · Class II · 21 CFR 886.5201

FDA Product Code QIU: Intense Pulsed Light Device For Managing Dry Eye

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.

Leading manufacturers include Lumenis, Ltd..

1
Total
0
Cleared
309d
Avg days
2021
Since

List of Intense Pulsed Light Device For Managing Dry Eye devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Intense Pulsed Light Device For Managing Dry Eye devices (product code QIU). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Ophthalmic FDA review panel. Browse all Ophthalmic devices →