iLux

Basic Information

• Brand Name: iLux
• Primary DI: 00864461000401
• Version / Model: 2020
• Catalog Number: 2020
• 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: 2
• Public Version Date: 2019-10-25
• Public Version Status: Update
• Public Device Record Key: aada5a5b-df68-42da-984c-03a3277477fd

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
58217	Eyelid thermal pulsation system control unit	An electrically-powered ophthalmic device intended to control the application of heat and pressure (intermittent pressure massage) applied to the eyelids during treatment of lid margin disease (LMD), Meibomian gland dysfunction (MGD) and/or evaporative dry eye. It typically includes controls, integrated software, and a visual display unit (VDU) and is designed to control the heat and pressure supply that are applied via an attached disposable applicator (not included).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864461000401	GS1

Premarket Submissions

Submission Number	Supplement Number
K172645	000