QIU

Intense Pulsed Light Device For Managing Dry Eye

Product code

QIU

Device name

Intense Pulsed Light Device For Managing Dry Eye

Device class

Class 2

21 CFR

21 CFR 886.5201

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).