iLux

Primary DI
00864461000401
Brand
iLux
Company
Alcon Laboratories, Inc.
Model
2020
Catalog number
2020
Published
2018-11-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00864461000401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864461000401008644610004018644610004010864461000401

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008018525
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658564520CLAREON VIVITY PRO TORICVNYWT9VNYWT9-0652026-11-05
00380658564537CLAREON VIVITY PRO TORICVNYWT9VNYWT9-0702026-11-05
00380658564544CLAREON VIVITY PRO TORICVNYWT9VNYWT9-0752026-11-05
00380658564551CLAREON VIVITY PRO TORICVNYWT9VNYWT9-0802026-11-05
00380658564568CLAREON VIVITY PRO TORICVNYWT9VNYWT9-0852026-11-05
00380658564575CLAREON VIVITY PRO TORICVNYWT9VNYWT9-0902026-11-05
00380658564582CLAREON VIVITY PRO TORICVNYWT9VNYWT9-0952026-11-05
00380658564599CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1002026-11-05
00380658564605CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1052026-11-05
00380658564612CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1102026-11-05
00380658564629CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1152026-11-05
00380658564636CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1202026-11-05
00380658564643CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1252026-11-05
00380658564650CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1302026-11-05
00380658564667CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1352026-11-05
00380658564674CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1402026-11-05
00380658564681CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1452026-11-05
00380658564698CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1502026-11-05
00380658564704CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1552026-11-05
00380658564711CLAREON VIVITY PRO TORICVNYWT9VNYWT9-1602026-11-05

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
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