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Deka Smartxide Touch M110C1

by El.en. SpA

Deka Smartxide Touch M110C1 is a Class II device made by El.en. SpA, cleared under FDA 510(k) K133895 on 5 Sep 2014 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 08057017760153), 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) K133895

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 Number08057017760153 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133895 Date5 Sep 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133895 decided 5 Sep 2014 Active
  • FDA GUDID UDI-DI 08057017760153 listed 13 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133895
  2. Listed FDA GUDID 08057017760153

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Deka Smartxide Touch
Generic name
Dermatological carbon dioxide laser system
Model / Ref / Catalog
M110C1
Primary DI / UDI-DI
08057017760153
510(k) Number
FDA product code
GEX
GMDN term
Dermatological carbon dioxide laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dermatological carbon dioxide laser system

Cleared under the same submission (K133895)

Similar devices

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

Other devices from El.en. SpA

See all devices from El.en. SpA →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)