MTONE EVO

GUDID 08057622080011

M & T SRL

Dermatological diode laser system

• Primary Device ID: 08057622080011
• NIH Device Record Key: f17b17ff-81d1-49ec-841e-ebb2d68c7836
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTONE EVO
• Version Model Number: Mtone evo lite
• 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	08057622080011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240604

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 [MTONE EVO]

• 08057622080011: Mtone evo lite
• 08057622080004: Mtone evo