DeviceClearance

Product code QIU— Ophthalmic

Lumenis Stellar M22

Classification name
Intense Pulsed Light Device For Managing Dry Eye
Device class
Class 2
Regulation
21 CFR 886.5201
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QIU under 21 CFR 886.5201, via openFDA

Market context for product code QIU

FDA has cleared 1 device under product code QIU, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QIU

Recent clearances under product code QIU

Data sourced from openFDA. This site is unofficial and independent of the FDA.