Product code QIU

Device name

Intense Pulsed Light Device For Managing Dry Eye

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.5201

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset