WAVENET

GUDID 00380659908163

WAVENET PLANNING SOFTWARE

Alcon Laboratories, Inc.

Laser application software

• Primary Device ID: 00380659908163
• NIH Device Record Key: d380e989-d255-4f92-9ae8-4b15ef065011
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVENET
• Version Model Number: 8065990816
• 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

Customer Support Contacts

• Phone: 1(800)-862-5266
• Email: web.masterus@alcon.com
• Phone: 1(800)-862-5266
• Email: web.masterus@alcon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659908163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020050

FDA Product Code

• LZS: Excimer Laser 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-08

On-Brand Devices [WAVENET]

• 00380659908170: ALLEGRETTO WAVE EYE-Q EXCIMER
• 00380659908163: WAVENET PLANNING SOFTWARE