Stellar™ M22

GUDID 07290109145167

LUMENIS LTD.

Multi-modality skin surface treatment system

• Primary Device ID: 07290109145167
• NIH Device Record Key: 22e2388f-67c5-4c41-9394-e40b1985bf13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stellar™ M22
• Version Model Number: Stellar LMX, AES
• 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: 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	07290109145167 [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: 2021-03-12
• Device Publish Date: 2021-03-04

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