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Mtone Evo

FDA UDI

Class II (US FDA UDI)

by M & T Srl

Identity

Trade Name
MTONE EVO FDA UDI
Generic Name
Dermatological diode laser system FDA UDI
Model / Reference
Mtone evo FDA UDI

Identifiers

Primary DI / UDI-DI
08057622080004 FDA UDI
510(k) Number
K240604 FDA UDI
FDA Product Code
GEX FDA UDI
ONE FDA UDI
ONF FDA UDI
ONG FDA UDI
GMDN Term
Dermatological diode laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Dermatological solid-state laser systemDermatological diode laser systemCosmetic red-light phototherapy system, professional

Mtone Evo by M & T Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cosmetic red-light phototherapy system, professional.

Cleared under the same submission

K240604 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
M & T Srl

Sources (1)

  • FDA UDI 267a4787-134a-4a04-a609-e996acc09e16 33 fields · synced Jun 8, 2026