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Mtone Evo Lite

by M & T SRL

Mtone Evo Lite is a Class II device made by M & T SRL, cleared under FDA 510(k) K240604 on 20 Sep 2024 and listed in FDA GUDID since 15 Apr 2025 (UDI-DI 08057622080134), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K240604

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08057622080134 UDI-DI Date15 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240604 Date20 Sep 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240604 decided 20 Sep 2024 Active
  • FDA GUDID UDI-DI 08057622080134 listed 15 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240604
  2. Listed FDA GUDID 08057622080134

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mtone Evo
Generic name
Dermatological diode laser system
Model / reference
MTONE EVO LITE
Primary DI / UDI-DI
08057622080134
510(k) Number
FDA product code
GEX, ONE, ONF, ONG
GMDN term
Dermatological diode laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

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

Cleared under the same submission (K240604)

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from M & T SRL

  • Mtone Evo

    Class II

  • MT ONE MTONE/Dus

    Class II

  • Mt One Diamond Mtone Diamond

    Class II

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)