AcuPulse™ Upgrade Kit 40ST to 40 AES-A

GUDID 07290109142869

Additional DM UDI: 07290109144054; 07290109144061; 07290109144078; 07290109144122

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system

• Primary Device ID: 07290109142869
• NIH Device Record Key: 1724d80b-4e54-4673-aaec-b63e81103d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuPulse™ Upgrade Kit 40ST to 40 AES-A
• Version Model Number: AcuPulse™ Upgrade Kit 40ST to 40 AES-A
• 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: false
• 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	07290109142869 [Primary]
GS1	07290109144047 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100415

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[07290109142869]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-27
• Device Publish Date: 2016-09-19

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