iLux 2020-D

GUDID 00864461000418

Alcon Laboratories, Inc.

Eyelid thermal pulsation system applicator

• Primary Device ID: 00864461000418
• NIH Device Record Key: a926a288-b9fe-4403-90a4-ccd812440ab0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLux
• Version Model Number: 2020-D
• Catalog Number: 2020-D
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00864461000418 [Primary]
GS1	10864461000415 [Unit of Use]

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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2018-11-05

On-Brand Devices [iLux]

• 00864461000418: 2020-D
• 00864461000401: 2020