WAVELIGHT EX500 EXCIMER LASER 8065990794

GUDID 00380659907944

WAVELIGHT EX500 EX LASER US

Alcon Laboratories, Inc.

Ophthalmic excimer laser system

• Primary Device ID: 00380659907944
• NIH Device Record Key: 35057b0a-3a06-4173-9d96-f5c655d80948
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Version Model Number: 8065990794
• Catalog Number: 8065990794
• 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: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound
• Weight: 1200 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659907944 [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

Devices Manufactured by Alcon Laboratories, Inc.

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• 20380650004684 - UNITY: 2024-11-27 27GA Infusion Cannula (includes TMD) – for use with 4mm/6 mm ES
• 20380650004707 - Alcon: 2024-11-27 Nano Sleeves Small Parts Kit
• 20380650004783 - UNITY: 2024-11-27 25+ UNITY TOTALPLUS Posterior Pack, UES HyperVit 30K, WA
• 10380657531759 - UNITY: 2024-11-27 25GA 10K Long Vitrectomy Probe
• 10380657531766 - UNITY: 2024-11-27 25+ ULTRAVIT 10K Probe
• 10380657530660 - UNIPURE & UNIFEYE: 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated