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Data / Medical devices / Italy / El.en. Electronic Engineering SPA

El.en. Electronic Engineering SPA: FDA-registered device maker in CALENZANO Firenze, Italy, 46 510(k) clearances

El.en. Electronic Engineering SPA is registered with the FDA (registration 3001431138) in CALENZANO Firenze, Italy. It lists 13 device types. The FDA files 46 510(k) clearances under its listings, the newest dated August 19, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch El.en. Electronic Engineering SPA
FDA registration number
3001431138
Address
17 Via Baldanzese, CALENZANO Firenze, Italy, 50041
Owner or operator
EL.EN. ELECTRONIC ENGINEERING SPA (9057711)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
February 9, 2004
Registered through
2026
Brand names listed
ALLORA PRO, BioStimul handpiece, Burian Pro, Cynosure Cellulaze - SLT II, Cynosure SLT II, Cynosure Smartlipo Triplex, Cynosure Smartskin +, DEKA AGAIN PRO and more

Devices it lists

DeviceProduct codeClassRoleSource
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Manufactureraccessdata.fda.gov
Laser For Disruption Of Adipocyte Cells For Aesthetic UsePKT2Manufactureraccessdata.fda.gov
Laser, Cellulite AppearanceOYW2Manufactureraccessdata.fda.gov
Laser, Dental, Soft TissueNVK2Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Manufactureraccessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced HeatPBX2Manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional OutputONG2Manufactureraccessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal EffectONF2Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Manufactureraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 19, 2026K261964ECHOLASER X4GEXSubstantially EquivalentElesta S.P.Aaccessdata.fda.gov
April 2, 2026K260647SPECCHIOPBXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
August 6, 2025K251432OloGEXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
February 26, 2025K250281DEKA LOTUSONFSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
February 19, 2025K243588Single Use CO2 Laser Fiber (HAF005001)GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
June 21, 2024K241459MOTUS PRO FamilyGEXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
May 16, 2024K240752DEKA TOROGEXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
May 16, 2024K233473DEKA LOTUSONFSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
April 10, 2024K234057NIRVANAGEXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
March 20, 2024K240537SMARTXIDE PROGEXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
March 12, 2024K240497Smartxide Tetra ProGEXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
March 8, 2024K240396Elite iQ PRO (M122K1)GEXSubstantially EquivalentCynosure, LLCaccessdata.fda.gov
February 6, 2024K233416Cryojet Plus (SHE-ACP001-1)GEXSubstantially EquivalentBeijing Sano Laser S&T Development Co.,Ltdaccessdata.fda.gov
December 19, 2023K233470DEKA LILYNGXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
October 27, 2023K233090DEKA AGAIN PRO familyGEXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
September 26, 2023K231971DEKA PHYSIQ 360PKTSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
September 1, 2023K232334DEKA SIMONIPFSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
June 2, 2023K231309SCAR 3GEXSubstantially EquivalentEl.En Electroinc Engineering Spaaccessdata.fda.gov
January 4, 2023K222221DEKA HELIXGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
May 3, 2022K213594ECHOLASER X4GEXSubstantially EquivalentElesta S.P.Aaccessdata.fda.gov
March 11, 2022K213658DEKA SMARTPERIONVKSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
October 21, 2021K212270DEKA LipoAIGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
October 15, 2021K211091Deka Tiac IIPBXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
August 23, 2021K203396DEKA SMARTPERIONVKSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
July 6, 2021K211821DEKA Motus AZGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
April 26, 2021K202258ERISE Laser handpieceGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
November 25, 2020K202079PhysiqIPFSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
March 9, 2020K193426Elite iQGEXSubstantially EquivalentCynosure, LLCaccessdata.fda.gov
December 16, 2019K192539Deka LuxeaGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
September 17, 2019K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 2, 2018K181867Deka Smartxide2 TrioGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
August 30, 2018K181486DEKA Motus AYGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
February 21, 2018K180193DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)GEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
November 17, 2017K172363DEKA SMARTXIDE ULTRASPEEDGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
November 17, 2017K172362DEKA SMARTXIDE TOUCHGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
June 19, 2017K162886DEKA MOTUS AXGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
September 5, 2014K133895DEKA SMARTXIDE LASER SYSTEMGEXSubstantially EquivalentEl.En S.P.A.accessdata.fda.gov
March 29, 2013K123407CELLULAZE LASEROYWSubstantially EquivalentCynosure, Inc.accessdata.fda.gov
February 1, 2013K113504DEKA SMARTXIDE AND DELIVERY ACCESSORIESGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
January 26, 2012K102541CYNOSURE CELLULAZE LASEROYWSubstantially EquivalentCynosure, Inc.accessdata.fda.gov
September 3, 2009K091537CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTHGEXSubstantially EquivalentCynosure, Inc.accessdata.fda.gov
August 27, 2009K082040MINISILK FTONFSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
May 5, 2008K081181SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASERGEXSubstantially EquivalentCynosure, Inc.accessdata.fda.gov
December 27, 2007K072159SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNERGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
October 31, 2006K062321SMARTLIPO ND:YAG LASERGEXSubstantially EquivalentCynosure, Inc.accessdata.fda.gov
October 1, 2003K031440SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASERGEXSubstantially EquivalentCynosure, Inc.accessdata.fda.gov

Compare with other makers

Updated August 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.