Skip to content

El.En Electronic Engineering Spa

Also registered as El..En. Electroic Engineering Spa

Country not established FDA

Devices
28
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What El.En Electronic Engineering Spa makes

El.En Electronic Engineering Spa manufactures a range of laser systems and medical devices for dermatological and aesthetic treatments, including CO₂ laser platforms like the SMARTXIDE series (SMARTXIDE2 Trio, SMARTXIDE Ultraspeed, and SMART US20D with dot scanner), fractional laser devices (MINISILK FT), and diode lasers (ASA LASER SH1). Their portfolio also includes medical lasers for tissue ablation and skin resurfacing, such as the DEKA SYNCHRO REPLA:Y and DEKA SYNCHRO FT, as well as the Physiq system for non-invasive skin treatments. Additional offerings include the ECHOLASER X4 for ultrasound-guided procedures and the Deka Tiac II for dermatological applications.

These devices are classified under Class II in the US regulatory framework, with most entries supported by FDA 510(k) clearances. The company’s products are listed in the FDA’s 510(k) registry, reflecting their authorised status for commercial distribution in the United States. El.En Electronic Engineering Spa operates from the US, adhering to regulatory requirements for Class II medical devices.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue28

Newest first, rows 1-28 of 28

Search and filter all 28 devices
Skip device list

  • Deka Synchro Repla:y Family Of Laser Systems Ref K150516

    Class II
    Active 510(k) 510(k) II

  • Deka Tiac 1 Ref K183371

    Class II
    Active 510(k) 510(k) II

  • Deka Luxea Ref K192539

    Class II
    Active 510(k) 510(k) II

  • Deka Smartxide2 Trio Ref K181867

    Class II
    Active 510(k) 510(k) II

  • Deka Synchro Ft Ref K103288

    Class II
    Active 510(k) 510(k) II

  • Deka Synchro Repla: Y Family Of Laser Systems Ref K131095

    Class II
    Active 510(k) 510(k) II

  • Asa Laser SH1 Ref K122125

    Class II
    Active 510(k) 510(k) II

  • Deka Tiac II Ref K211091

    Class II
    Active 510(k) 510(k) II

  • Physiq Ref K202079

    Class II
    Active 510(k) 510(k) II

  • Smart CO2 (Smartxide, Smart US20D) With Dot Scanner Ref K072159

    Class II
    Active 510(k) 510(k) II

  • Minisilk Ft Ref K082040

    Class II
    Active 510(k) 510(k) II

  • Echolaser X4 Ref K181510

    Class II
    Active CE MDR 510(k) 510(k) II

  • Deka Smartxide Ultraspeed Ref K172363

    Class II
    Active 510(k) 510(k) II

  • DEKA Motus AZ Ref K211821

    Class II
    Active 510(k) 510(k) II

  • DEKA LipoAI Ref K212270

    Class II
    Active 510(k) 510(k) II

  • Smartxide 50 Hs/Ms Ref K101904

    Class II
    Active 510(k) 510(k) II

  • Derma Yag Ref K062762

    Class II
    Active 510(k) 510(k) II

  • Synchro Hp Platform Ref K082039

    Class II
    Active 510(k) 510(k) II

  • Scar 3 Ref K211362

    Class II
    Active 510(k) 510(k) II

  • Deka Helix Ref K222221

    Class II
    Active 510(k) 510(k) II

  • Deka Motus Ax Ref K162886

    Class II
    Active 510(k) 510(k) II

  • Deka Smartperio Ref K203396

    Class II
    Active 510(k) 510(k) II

  • DEKA Motus AY Ref K181486

    Class II
    Active 510(k) 510(k) II

  • Deka Smartxide Touch Ref K172362

    Class II
    Active 510(k) 510(k) II

  • DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) Ref K180193

    Class II
    Active 510(k) 510(k) II

  • Deka Smartxide And Delivery Accessories Ref K113504

    Class II
    Active 510(k) 510(k) II

  • Deka Smartperio Ref K213658

    Class II
    Active 510(k) 510(k) II

  • ERISE Laser handpiece Ref K202258

    Class II
    Active 510(k) 510(k) II

Rows 1-28 of 28

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • El.en. Electronic Engineering SpA CALENZANO Firenze · IT FEI 3001431138

Frequently asked questions

How many devices does El.En Electronic Engineering Spa have in the registry?

The registry currently lists 28 devices for El.En Electronic Engineering Spa. Devices recorded under merged duplicate company entries are counted once.

Which registries list El.En Electronic Engineering Spa's devices?

Among its 28 most recently registered devices, El.En Electronic Engineering Spa has devices listed in FDA 510(k) (28 devices).

What risk classes do El.En Electronic Engineering Spa's devices fall under?

Among its 28 most recently registered devices, the classes recorded for El.En Electronic Engineering Spa's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from El.En Electronic Engineering Spa in the registry?

The most recently registered devices listed for El.En Electronic Engineering Spa include DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS, Deka Tiac 1, Deka Luxea and Deka Smartxide2 Trio.

Which FDA establishments are linked to El.En Electronic Engineering Spa?

1 FDA establishment is linked to El.En Electronic Engineering Spa in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.