iLux 2020

GUDID 00864461000401

Alcon Laboratories, Inc.

Eyelid thermal pulsation system control unit

• Primary Device ID: 00864461000401
• NIH Device Record Key: aada5a5b-df68-42da-984c-03a3277477fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLux
• Version Model Number: 2020
• Catalog Number: 2020
• 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: false
• 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	00864461000401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172645

FDA Product Code

• ORZ: Eyelid Thermal Pulsation System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-25
• Device Publish Date: 2018-11-05

On-Brand Devices [iLux]

• 00864461000418: 2020-D
• 00864461000401: 2020