Lumenis Pulse 30H

GUDID 07290109140698

LUMENIS LTD.

General/multiple surgical solid-state laser system

• Primary Device ID: 07290109140698
• NIH Device Record Key: 1c586b93-d077-4b7b-bae8-16cbac484b69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumenis Pulse 30H
• Version Model Number: Lumenis Pulse 30H
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109140698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100228

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

On-Brand Devices [Lumenis Pulse 30H]

• 07290109140698: Lumenis Pulse 30H
• 07290109145990: Lumenis Pulse 30H
• 07290109145983: Lumenis Pulse 30H
• 07290109147390: Lumenis Pulse 30H
• 07290109147314: Lumenis Pulse 30H