WAVELIGHT REFRACTIVE SUITE

GUDID 00380659906060

ALLEGRO ANALYZER. The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.

Alcon Laboratories, Inc.

Corneal topography system Corneal topography system

• Primary Device ID: 00380659906060
• NIH Device Record Key: 35284864-6fd0-45ea-8c7f-661c19933c4d
• Commercial Distribution Discontinuation: 2014-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WAVELIGHT REFRACTIVE SUITE
• Version Model Number: 8065990606
• 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

Customer Support Contacts

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

Device Dimensions

• Weight: 188 Pound
• Weight: 188 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659906060 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

On-Brand Devices [WAVELIGHT REFRACTIVE SUITE]

• 00380659908965: STAND ALONE PATIENT BED
• 00380659907463: REFRACTIVE SUITE SWIVEL BED
• 00380659906060: ALLEGRO ANALYZER. The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devi
• 00380650001108: STAND ALONE PATIENT BED