M22 ResurFX Handpiece

GUDID 07290109143026

LUMENIS LTD.

Multi-modality skin surface treatment system

• Primary Device ID: 07290109143026
• NIH Device Record Key: 1d641dc2-156a-4dee-910c-a9fb1b492872
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M22 ResurFX Handpiece
• Version Model Number: M22 ResurFX Handpiece
• 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

Customer Support Contacts

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109143026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142860

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2016-09-13

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• 07290109147192 - Lumenis Pulse 120H: 2025-02-26
• 07290109147208 - Lumenis Pulse, Moses 2.0 (INT): 2025-02-26
• 07290109147215 - Lumenis Pulse 120H: 2025-02-26
• 07290109147222 - Lumenis Pulse 120H: 2025-02-26
• 07290109147291 - Lumenis Pulse 120H: 2025-02-26