FDA.reportPublic FDA data

EL.EN. ELECTRONIC ENGINEERING SPA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30014311383001431138EL.EN. ELECTRONIC ENGINEERING SPA1N2026-01-0117 VIA BALDANZESE CALENZANO Firenze IT 50041

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
622691858484849K261964ECHOLASER X4GEX2026-08-19
622691624060252K260647SPECCHIOPBX2026-04-02
622691678093337K251432OloGEX2025-08-06
622691504452694K250281DEKA LOTUSONF2025-02-26
622691835254601K243588Single Use CO2 Laser Fiber (HAF005001)GEX2025-02-19
622691066164088K241459MOTUS PRO FamilyGEX2024-06-21
622691294642335K240752DEKA TOROGEX2024-05-16
622691073665165K240537SMARTXIDE PROGEX2024-03-20
622691478478190K240497Smartxide Tetra ProGEX2024-03-12
622691682270822K240396Elite iQ PRO (M122K1)GEX2024-03-08
622691559836530K234057NIRVANAGEX2024-04-10
622692027463031K233473DEKA LOTUSONF2024-05-16
622691926837176K233470DEKA LILYNGX2023-12-19
622691802752695K233416Cryojet Plus (SHE-ACP001-1)GEX2024-02-06
622691178179350K233090DEKA AGAIN PRO familyGEX2023-10-27
622691501919946K232334DEKA SIMONIPF2023-09-01
622691287917830K231971DEKA PHYSIQ 360PKT2023-09-26
622691086985216K231309SCAR 3GEX2023-06-02
622691570645259K222221DEKA HELIXGEX2023-01-04
622691941312970K213658DEKA SMARTPERIONVK2022-03-11
622691893230710K213594ECHOLASER X4GEX2022-05-03
622691200069342K212270DEKA LipoAIGEX2021-10-21
622691780214402K211821DEKA Motus AZGEX2021-07-06
622691277957676K211091Deka Tiac IIPBX2021-10-15
622691178023614K203396DEKA SMARTPERIONVK2021-08-23
622691311051455K202258ERISE Laser handpieceGEX2021-04-26
622692016956028K202079PhysiqIPF2020-11-25
622691744263636K193426Elite iQGEX2020-03-09
622691214299580K192539Deka LuxeaGEX2019-12-16
622691313658336K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermGEX2019-09-17
622691039118396K183371Deka Tiac 1PBX2019-12-03
622691839378159K181867Deka Smartxide2 TrioGEX2018-10-02
622692032601481K181510ECHOLASER X4GEX2018-09-04
622691602808365K181486DEKA Motus AYGEX2018-08-30
622691018272131K180193DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)GEX2018-02-21
622691982757747K172363DEKA SMARTXIDE ULTRASPEEDGEX2017-11-17
622691806828355K172362DEKA SMARTXIDE TOUCHGEX2017-11-17
622691916437796K162886DEKA MOTUS AXGEX2017-06-19
622691286292756K150516DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMSGEX2015-04-13
622691525891343K133895DEKA SMARTXIDE LASER SYSTEMGEX2014-09-05
622691019634874K131095DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMSGEX2013-12-05
622691484822435K123407CELLULAZE LASEROYW2013-03-29
622691316838606K122125ASA LASER SH1ILY2013-01-25
622691072099231K113504DEKA SMARTXIDE AND DELIVERY ACCESSORIESGEX2013-02-01
622691430874493K102541CYNOSURE CELLULAZE LASEROYW2012-01-26
622691271327752K091537CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTHGEX2009-09-03
622691441932058K082040MINISILK FTONF2009-08-27
622691338180008K081181SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASERGEX2008-05-05
622691559131233K072159SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNERGEX2007-12-27
622691621448810K062321SMARTLIPO ND:YAG LASERGEX2006-10-31
622691519169238K051537HILT FAMILY LASER: HILT I, HILT II, HILT IIIILY2005-09-26
622691786897169K031440SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASERGEX2003-10-01
622691390321342
622691570244641
622691590509238

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX362026-08-19
PBX32026-04-02
ONF32025-02-26
IPF22023-09-01
NVK22022-03-11
OYW22013-03-29
ILY22013-01-25
NGX12023-12-19
PKT12023-09-26

PMN#