510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200028Unknown

Lumenis Stellar M22

Lumenis Ltd, Yokneam, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN200028 is the FDA 510(k) clearance record for Lumenis Stellar M22, a class II device, cleared for Lumenis, Ltd. on under FDA product code QIU (Intense Pulsed Light Device For Managing Dry Eye). FDA's definition for product code QIU reads: "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...". FDA records list 83 510(k) clearances for Lumenis, Ltd., from to . As of , FDA records show no recalls naming DEN200028.

Clearance record

Decision date
Received
(309 days to decision)
Product code
QIU Intense Pulsed Light Device For Managing Dry Eye
Regulation
21 CFR 886.5201
Device class
Class II
Review panel
Ophthalmic
Applicant
Lumenis, Ltd. 6 Hakidma St. P.O. Box 240, Yokneam, IL
Third party review
No

Clearances, product code QIU

Trailing 12 months

FDA records hold no clearances under product code QIU in the trailing twelve months.

FDA records show no clearances under product code QIU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QIU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260