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Deka Helix

by El.En Electronic Engineering Spa 510(k)

Active United States

510(k) K222221

Overview

The Deka Helix is a powered laser surgical instrument intended for use in general and plastic surgery procedures. It delivers laser energy to perform precise tissue cutting and coagulation as required by the surgical application.

The device is manufactured by El.En Electronic Engineering Spa in Calenzano, Italy, and is classified as a Class II device with special controls under product code GEX. It received FDA 510(k) clearance (K222221) on January 4, 2023, following a substantially equivalent determination. The device is supplied as a single unit and is subject to the applicable regulatory requirements for marketed medical devices.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222221 Date4 Jan 2023ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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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