Digital Duet

GUDID 07290109145181

LUMENIS INC.

General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system

• Primary Device ID: 07290109145181
• NIH Device Record Key: 9f683ab8-c691-4b13-96f1-c20f112a614a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Duet
• Version Model Number: Selecta Duet Digital
• 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: 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	07290109145181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081704

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: 2021-03-30
• Device Publish Date: 2021-03-22

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
• 07290109145181 - Digital Duet: 2021-03-30
• 17290109140787 - Acculite EndoOcular: 2020-02-24
• 07290109140827 - Acculite EndoOto: 2020-02-24
• 17290109140831 - Acculite EndoOto: 2020-02-24