Vision One

GUDID 00810096330116

Lumenis Be, Inc.

Ophthalmic diode laser system

• Primary Device ID: 00810096330116
• NIH Device Record Key: 7f30c7e7-64a4-40fd-81ce-ed774f503f57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision One
• Version Model Number: Red
• Company DUNS: 118292380
• Company Name: Lumenis Be, 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	00810096330116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111213

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2023-04-10
• Device Publish Date: 2023-04-02

On-Brand Devices [Vision One]

• 00810096330147: Yellow
• 00810096330130: Y/R
• 00810096330123: G/R
• 00810096330116: Red
• 00810096330109: Green
• 00810096330093: G/Y
• 00810096330086: G/Y/R