Acculite™  EndoOto™

GUDID 17290109140817

LUMENIS INC.

Ophthalmic laser system beam guide

• Primary Device ID: 17290109140817
• NIH Device Record Key: 2a62cec9-f2e5-4bd2-91a0-24c7fdd310e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acculite™ EndoOto™
• Version Model Number: Gherini, 24ga Str, SmartScan, 200μm
• Company DUNS: 043618763
• Company Name: LUMENIS 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 408-764-3000
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109140810 [Primary]
GS1	17290109140817 [Package]; Contains: 07290109140810; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930981

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[17290109140817]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

Devices Manufactured by LUMENIS INC.

• 07290109140612 - Smart LIO: 2023-06-22
• 07290109143835 - Smart LIO: 2023-06-22
• 07290109143842 - Smart LIO: 2023-06-22
• 07290109143637 - Smart-V Illumination Add-on: 2022-03-31
• 07290109145181 - Digital Duet: 2021-03-30
• 17290109140787 - Acculite EndoOcular: 2020-02-24
• 07290109140827 - Acculite EndoOto: 2020-02-24
• 17290109140831 - Acculite EndoOto: 2020-02-24