BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    EL.EN. ELECTRONIC ENGINEERING SPA

    Reg #: 3001431138 · FEI: 3001431138 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    68
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    EL.EN. ELECTRONIC ENGINEERING SPA
    Registration Number
    3001431138
    FEI Number
    3001431138
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17 VIA BALDANZESE
    City
    CALENZANO Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K233416

    Owner / Operator

    Firm Name
    EL.EN. ELECTRONIC ENGINEERING SPA
    Operator Number
    9057711
    Address
    VIA BALDANZESE 17, --
    City
    CALENZANO
    State
    Firenze
    Postal Code
    50041
    Country
    IT
    Correspondent
    PAOLO - PERUZZI

    US Agent

    Business Name
    Emergo Global Consulting LLC
    Contact Name
    Greg Swanson
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Massager, Vacuum, Radio Frequency Induced Heat PBX
    Laser For Disruption Of Adipocyte Cells For Aesthetic Use PKT
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Laser, Dental, Soft Tissue NVK
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Lamp, Infrared, Therapeutic Heating ILY
    Laser, Cellulite Appearance OYW
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    Burian Pro DEKA SMARTXIDE ULTRASPEED DEKA LUXEA PLUS Cynosure Smartskin + body ESTIQ DEKA Smart US20D DEKA SMARTXIDE2 PHYSIQ 360 OLO LUVO PHYSIQ Thermaeye Plus TORO DEKA SYNCHRO REPLAY EXCELLIUM HP DEKA SYNCHRO REPLAY EXCELLIUM 3.4 DEKA SYNCHRO REPLAY PREMIUM 1.4.2 Cynosure SLT II Cynosure Smartlipo Triplex Elite iQ PRISMA DEKA SMARTPERIO DEKA SMARTXIDE TOUCH DEKA SMARTXIDE PUNTO DEKA SMARTXIDE TETRA SMARTXIDE TOUCH HEMERA DEKA SmartXide with DOT scanner DEKA SmartXide50 with DOT scanner MOTUS AZ+ MOTUS AZ SMARTLIPO DEKA SMARTLIPO DEKA LipoAI DEKA SMARTXIDE² MONA LISA TOUCH LILY PRISMA EMS Smartxide UltraSpeed2 BioStimul handpiece DEKa Synchro Repla:Y Excellium HP DEKA Synchro Repla:Y Premium 1.4.2 DEKA Synchro Repla:Y Excellium 3.4 Cynosure Cellulaze - SLT II ONDA PRO SIMON PHYSIQ 360 EMS Elite iQ Pro Echolaser X4 DEKA HELIX DEKA SmartXide SMARTXIDE PRO SCAR 3 SCAR 3 PRO ERISE laser handpiece SMARTXIDE TETRA PRO MOTUS PRO MOTUS PRO AX PLUS HANDPIECE SYMPHONY ALLORA PRO EXIRA DEKA AGAIN PRO DEKA MOTUS AX DEKA MOTUS AY LEVANTA DEKA SMARTXIDE² TRIO IMLIGHT MULTIPULSE PRO DUO MULTIPULSE PRO 60

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)