iLux

Basic Information

• Brand Name: iLux
• Primary DI: 00864461000418
• Version / Model: 2020-D
• Catalog Number: 2020-D
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-05
• Public Version: 5
• Public Version Date: 2025-01-20
• Public Version Status: Update
• Public Device Record Key: a926a288-b9fe-4403-90a4-ccd812440ab0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	886.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58218	Eyelid thermal pulsation system applicator, single-use	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864461000418	GS1
Package	10864461000415	GS1		10	In Commercial Distribution