M22™ Q-Switched Head

GUDID 07290117772744

LUMENIS BE LTD

Multi-modality skin surface treatment system

• Primary Device ID: 07290117772744
• NIH Device Record Key: a9139d5d-fc0f-4588-8a25-061015ca84a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M22™ Q-Switched Head
• Version Model Number: NA
• Company DUNS: 600763501
• Company Name: LUMENIS BE 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	07290117772744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250809

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2025-12-29
• Device Publish Date: 2025-12-21

On-Brand Devices [M22™ Q-Switched Head]

• 07290117770184: M22™ Q-Switched Head
• 07290117772744: NA