VersaPulse PowerSuite 30W

GUDID 07290109140568

LUMENIS LTD.

General/multiple surgical solid-state laser system

• Primary Device ID: 07290109140568
• NIH Device Record Key: 447d06cc-cc30-4902-8a6f-d5ca5d665867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaPulse PowerSuite 30W
• Version Model Number: VersaPulse PowerSuite 30W
• Company DUNS: 600166524
• Company Name: LUMENIS LTD.
• 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	07290109140568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011703

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: 2016-08-23

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• 07290109144931 - Stellar SapphireCool LG 15x35: 2023-08-16
• 07290109144948 - Stellar SapphireCool LG 8x15: 2023-08-16
• 07290109146676 - SurgiTouch Scanner: 2022-09-30
• 07290109146133 - UltraPulse® DUO: 2022-09-28 UltraPulse DUO
• 07290109147055 - VersaPulse PowerSuite 80/100W: 2022-09-27
• 07290109147062 - VersaPulse PowerSuite 80/100W: 2022-09-27