UltraPulse® Focused Incisional Handpiece Set

GUDID 07290109141831

Additional DM UDI: 07290109144030 07290109144009 07290109144016

LUMENIS LTD.

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

• Primary Device ID: 07290109141831
• NIH Device Record Key: c96ac491-11df-4ea3-8c96-63686d24147b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraPulse® Focused Incisional Handpiece Set
• Version Model Number: UltraPulse® Focused Incisional Handpiece Set
• 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
• 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	07290109141831 [Primary]
GS1	07290109144023 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151331

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

[07290109141831]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-08-28

On-Brand Devices [UltraPulse® Focused Incisional Handpiece Set]

• 07290109141831: Additional DM UDI: 07290109144030 07290109144009 07290109144016
• 07290109141619: Additional DM UDI: 07290109144528