Selecta Duet

GUDID 07290109143316

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

• Primary Device ID: 07290109143316
• NIH Device Record Key: a553e804-b7c9-42f9-a312-6b6fa72109f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selecta Duet
• Version Model Number: Selecta Duet
• 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

Customer Support Contacts

• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109143316 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-25

On-Brand Devices [Selecta Duet]

• 07290109143316: Selecta Duet
• 07290109143309: Selecta Duet
• 07290109143255: Selecta Duet