Vision One

GUDID 00810096330086

Lumenis Be, Inc.

Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system Ophthalmic diode laser system

• Primary Device ID: 00810096330086
• NIH Device Record Key: 6a4a4c9f-e992-4116-a38d-db198b3fca04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision One
• Version Model Number: G/Y/R
• 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	00810096330086 [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