WAVELIGHT ALLEGRO TOPOLYZER

GUDID 00380659907678

WAVELIGHT TOPOLYZER VARIO: 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

• Primary Device ID: 00380659907678
• NIH Device Record Key: d3b78a27-3884-46a9-b725-61399994b48e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVELIGHT ALLEGRO TOPOLYZER
• Version Model Number: 8065990767
• 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
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com

Device Dimensions

• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound
• Weight: 70.4 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659907678 [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: 2014-09-24

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• 10380650002379 - UNITY TETRASPOT: 2024-07-11 27GA TETRASPOT MultiSpot Laser Probe
• 00380650002433 - UNITY: 2024-07-11 LASER KIT
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• 00380650002969 - UNITY: 2024-07-11 UNITY VCS System (Anterior/Posterior)
• 10380650003390 - UNITY: 2024-07-11 UNITY Cataract FMS Pack, 30° Balanced Tip with Ultra Infusion Sleeves
• 10380650003406 - UNITY: 2024-07-11 UNITY Cataract FMS Pack, 45° Balanced Tip with Ultra Infusion Sleeves