Stellar Optima System upgrade kit

GUDID 07290109145204

LUMENIS LTD.

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• Primary Device ID: 07290109145204
• NIH Device Record Key: e418c914-147f-43b9-8ad1-12c35be8221d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stellar Optima System upgrade kit
• Version Model Number: Stellar Optima System upgrade kit
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109145204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200028

FDA Product Code

• QIU: Intense Pulsed Light Device For Managing Dry Eye

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-04
• Device Publish Date: 2021-05-27

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