Stellar M22 Q-switched Nd:YAG upgrade

GUDID 07290109144788

LUMENIS LTD.

Multi-modality skin surface treatment system

• Primary Device ID: 07290109144788
• NIH Device Record Key: c7014ea9-d034-4d33-a489-2e0696d8e316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stellar M22 Q-switched Nd:YAG upgrade
• Version Model Number: Q-switched Nd:YAG upgrade
• 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	07290109144788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193500

FDA Product Code

• ONG: Powered Laser Surgical Instrument With Microbeam\Fractional Output

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: 2020-02-11
• Device Publish Date: 2020-02-03

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