iLux 8065000573

GUDID 00380650005731

Systane iLux2 Instrument

Alcon Laboratories, Inc.

Eyelid thermal pulsation system control unit

• Primary Device ID: 00380650005731
• NIH Device Record Key: 2042b5b2-7972-43f4-b7a7-c56dad6a0d98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLux
• Version Model Number: 2022
• Catalog Number: 8065000573
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380650005731 [Primary]

FDA Product Code

• ORZ: Eyelid Thermal Pulsation System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13

On-Brand Devices [iLux]

• 00864461000418: 2020-D
• 00864461000401: 2020
• 20380650005728: Systane iLux2 Meibography Tip
• 00380650005731: Systane iLux2 Instrument