FDA.reportPublic FDA data

iLux

Primary DI
00380650005748
Brand
iLux
Company
Alcon Laboratories, Inc.
Model
2022-PT
Catalog number
8065000574
Device description
Systane iLux2 Meibography Tip
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ORZEyelid Thermal Pulsation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORZEyelid Thermal Pulsation SystemOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20380650005728PackageGS13In Commercial Distribution
00380650005748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2038065000572820380650005728
00380650005748003806500057483806500057480380650005748

GMDN Terms#

Term, Definition table
TermDefinition
Meibomian gland image acquisition positioning-tipA noninvasive, non-powered device intended to be attached to the distal end of a hand-held meibomian gland imaging unit (e.g., meibomian gland camera or eyelid thermal pulsation unit with integrated camera) to provide a stable point of contact with the patient’s face during acquisition of the image(s). This is a reusable device.

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290117524077Tixel i NOVOXEL LTDORZ2026-04-06
07290117524084Tixel i HP NOVOXEL LTDORZ2026-04-06
00380650005731iLuxAlcon Laboratories, Inc.ORZ2026-03-13
20380650005728iLuxAlcon Laboratories, Inc.ORZ2026-03-13
00858027006549TearCare MGX System - TearCare MGX Technology KitSight Sciences, Inc.ORZ2025-04-30
00858027006297TearCare MGX System - TearCare MGX SmartLidsSight Sciences, Inc.ORZ2025-04-29
00858027006457TearCare System - TearCare SmartHub KitSight Sciences, Inc.ORZ2022-03-03
00858027006495TearCare System - TearCare SmartLidsSight Sciences, Inc.ORZ2022-03-03
00810051250022TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
00810051250077TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
10810051250029TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
10810051250074TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
00864461000401iLuxAlcon Laboratories, Inc.ORZ2018-11-05
00864461000418iLuxAlcon Laboratories, Inc.ORZ2018-11-05
00859623006315LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLETEARSCIENCE, INC.ORZ2016-12-24
20859623006333LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLETEARSCIENCE, INC.ORZ2016-12-24
00859623006711LIPIFLOW SYSTEM ACTIVATOR II CABLE KITTEARSCIENCE, INC.ORZ2016-12-24
00859623006117LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)TEARSCIENCE, INC.ORZ2016-09-23
20859623006135LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)TEARSCIENCE, INC.ORZ2016-09-23
00859623006216LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)TEARSCIENCE, INC.ORZ2016-09-23
00859623006414LIPIFLOW SYSTEM CONSOLETEARSCIENCE, INC.ORZ2016-09-23