Eyelite, PurePoint, Alcon

GUDID 00380655002018

Eyelite/PurePoint Eye Safety Filter

Alcon Laboratories, Inc.

General/multiple surgical frequency-doubled solid-state laser system

• Primary Device ID: 00380655002018
• NIH Device Record Key: 40cf2efc-4774-4001-99a6-22072b701bd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eyelite, PurePoint, Alcon
• Version Model Number: 8065-5002-01
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00380655002018 [Primary]

FDA Product Code

• HQF: Laser, ophthalmic

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: 2016-09-24

Devices Manufactured by Alcon Laboratories, Inc.

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• 10380650003345 - UNITY: 2024-11-27 27+ UNITY TOTALPLUS Posterior Pack, UES HyperVit 30K DS, WA DS
• 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