WaveLight 8065998437

GUDID 00380659984372

Diagnostic device to perform non-contact measurements of the corneal tomography, anterior chamber parameter, pupil diameter, axial length, and optical aberrations of the patient’s eye.

Alcon Laboratories, Inc.

Eye anterior segment analyser

• Primary Device ID: 00380659984372
• NIH Device Record Key: 71e6683b-5efd-4687-88c5-9af1f9991e31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveLight
• Version Model Number: 1023
• Catalog Number: 8065998437
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659984372 [Primary]

FDA Product Code

• LZS: Excimer Laser System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-20
• Device Publish Date: 2025-03-12

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• 00380659906503: Wavelight Lift Table Diagnostic
• 00380659984372: Diagnostic device to perform non-contact measurements of the corneal tomography, anterior chambe