FDA.reportPublic FDA data

iLux

Primary DI
00864461000418
Brand
iLux
Company
Alcon Laboratories, Inc.
Model
2020-D
Catalog number
2020-D
Published
2018-11-05
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172645000iLux Instrument, iLux DisposableTear Film Innovations, Inc.2017-12-26ORZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864461000418PrimaryGS10
10864461000415Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864461000418008644610004188644610004180864461000418
1086446100041510864461000415

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid thermal pulsation system applicatorAn ophthalmic device designed to apply heat and pressure (intermittent pressure massage) to the outer eyelid surface for treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It consists of two small plates, one positioned under the eyelid, and the other with heating/pulsing elements applied to the outside of the eyelid, and is used with a reusable control unit (not included). This is a single-use device.

Sterilization Methods#

Method table
Method

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
00380650005748iLuxAlcon Laboratories, Inc.ORZ2026-03-13
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
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