QIUClass II

Intense Pulsed Light Device For Managing Dry Eye

21 CFR 886.5201 / Ophthalmic

QIU is the FDA product code for Intense Pulsed Light Device For Managing Dry Eye, a class II device type, regulated under 21 CFR 886.5201. FDA's definition for this code 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 dysfunction, also known as evaporative dry eye or lipid deficiency dry eye". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2021-02-23, and no recalls.

Classification record

Product code: QIU
Device name: Intense Pulsed Light Device For Managing Dry Eye
FDA 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.
Regulation: 21 CFR 886.5201
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code QIU

By decision year

1 clearance under product code QIU with a decision year between 2021 and 2021, 2021 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QIU by decision year
Year	Clearances
2021	1

Applicants with the most clearances

Product code QIU

Applicants holding the most 510(k) clearances under product code QIU
Applicant	Clearances
Lumenis Ltd	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QIU

DEN200028Class IILumenis Stellar M22Lumenis, Ltd. / cleared 2021-02-23

Recent recalls

Product code QIU

FDA records show no recalls under product code QIU.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)