Array LaserLink

GUDID 07290109143545

LUMENIS INC.

Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface

• Primary Device ID: 07290109143545
• NIH Device Record Key: 8fba9387-9a61-4526-b522-cf8a94446280
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Array LaserLink
• Version Model Number: Array LaserLink
• Company DUNS: 043618763
• Company Name: LUMENIS INC.
• 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
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• Phone: 408-764-3000
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• Phone: 408-764-3000
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• Phone: 408-764-3000
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• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
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• Phone: 408-764-3000
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• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
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• Phone: 408-764-3000
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• Phone: 408-764-3000
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• Phone: 408-764-3000
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• Phone: 408-764-3000
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• Phone: 408-764-3000
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• Phone: 408-764-3000
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• 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
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• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
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• Phone: 408-764-3000
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Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109143545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130195

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2016-09-01

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• 17290109140787 - Acculite EndoOcular: 2020-02-24
• 07290109140827 - Acculite EndoOto: 2020-02-24
• 17290109140831 - Acculite EndoOto: 2020-02-24