AcuPulse™ Upgrade Kit 40 to 40AES-R

GUDID 07290109142890

Additional DM UDI: 07290109144054; 07290109144061; 07290109144047; 07290109144078

LUMENIS LTD.

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

• Primary Device ID: 07290109142890
• NIH Device Record Key: 6a3312b2-53ec-4c75-8ede-a6aad6817e66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuPulse™ Upgrade Kit 40 to 40AES-R
• Version Model Number: AcuPulse™ Upgrade Kit 40 to 40AES-R
• 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	07290109142890 [Primary]
GS1	07290109144122 [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

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

Moist Heat or Steam Sterilization

[07290109142890]

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

Devices Manufactured by LUMENIS LTD.

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• 07290109144924 - Stellar SapphireCool LG 6mm: 2023-08-16
• 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