MT ONE

GUDID 08057622080035

M & T SRL

Dermatological diode laser system

• Primary Device ID: 08057622080035
• NIH Device Record Key: 806c49ee-3b4e-42a4-b99c-a12f33fdfc73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MT ONE
• Version Model Number: MT ONE/D
• Company DUNS: 441794981
• Company Name: M & T SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	08057622080035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192856

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: 2025-04-23
• Device Publish Date: 2025-04-15

On-Brand Devices [MT ONE]

• 08057622080035: MT ONE/D
• 08057622080028: Mt one