FDA product code QIU

Intense Pulsed Light Device For Managing Dry Eye

Ophthalmic·Class 2·21 CFR 886.5201
US regulatory classifications
US Product Code (FDA)
QIU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 886.5201
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Intense Pulsed Light Device For Managing Dry Eye is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.