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Smartxide Pro

by El.En S.P.A. 510(k)

Active United States

510(k) K240537

Overview

The Smartxide Pro is a powered laser surgical instrument classified within the GEX category for use in general and plastic surgery and dermatology. It is a Class II medical device subject to special controls.

The device received FDA 510(k) clearance (K240537) on March 20, 2024, and is manufactured by El.En S.P.A. in Calenzano, Italy. It is supplied as a non-sterile, reusable instrument requiring appropriate cleaning and sterilization by the user prior to use.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK240537 Date20 Mar 2024ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Smartxide Pro used for?

    The Smartxide Pro is a powered laser surgical instrument intended for use in general and plastic surgery and dermatology, classified under the GEX product code for these surgical applications.

  • Is the Smartxide Pro sterile when supplied?

    No, the Smartxide Pro is supplied as a non-sterile instrument and must be cleaned and sterilized by the user before each use to ensure it is safe for surgical procedures.

  • Can the Smartxide Pro be reused?

    Yes, the Smartxide Pro is designed as a reusable instrument; however, it requires proper cleaning and sterilization by the user after each use to maintain safety and functionality.

  • Who manufactures the Smartxide Pro and where is it made?

    The Smartxide Pro is manufactured by El.En S.P.A. in Calenzano, Italy, as indicated in the device’s authorization and manufacturing details.