Eyelite, PurePoint, Alcon

GUDID 00380655002018

Eyelite/PurePoint Eye Safety Filter

Alcon Laboratories, Inc.

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

• 00047113604978 - Clear Care: 2024-03-27 Clear Care Cleaning & Disinfecting Solution Twin Pack 2 x 16 oz. plus 3 oz. Travel Size
• 00047113609027 - Clear Care: 2024-03-27 Clear Care Cleaning & Disinfecting Solution Twin Pack 2 x 12 oz.
• 00047113609034 - Clear Care: 2024-03-27 Clear Care Cleaning & Disinfecting Solution 3 oz. Travel Kit
• 00047113609126 - Clear Care: 2024-03-27 Clear Care Cleaning & Disinfecting Solution 12 oz.
• 00380657530571 - Centurion: 2023-05-02 Centurion Vision System With Active Sentry
• 10380650000535 - LENSX: 2022-11-14 LENSX LASER SOFTFIT PATIENT INTERFACE 10 PK, EO
• 20380650000549 - LENSX: 2022-11-14 LENSX SOFTFIT PATIENT INTERFACE NOMINAL,EO
• 20380650000556 - LENSX: 2022-11-14 LENSX SOFTFIT PATIENT INTERFACE STEEP,EO