WAVELIGHT REFRACTIVE SUITE

GUDID 00380650001108

STAND ALONE PATIENT BED

Alcon Laboratories, Inc.

Ophthalmic chair, line-powered

• Primary Device ID: 00380650001108
• NIH Device Record Key: 025b1997-accb-408a-b169-1c7055d2f547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVELIGHT REFRACTIVE SUITE
• Version Model Number: 8065000110
• 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: false
• 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	00380650001108 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-04
• Device Publish Date: 2021-02-24

On-Brand Devices [WAVELIGHT REFRACTIVE SUITE]

• 00380659908965: STAND ALONE PATIENT BED
• 00380659907463: REFRACTIVE SUITE SWIVEL BED
• 00380659906060: ALLEGRO ANALYZER. The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devi
• 00380650001108: STAND ALONE PATIENT BED