BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Echolaser X4

    Reg #: 3015077548 · FEI: 3015077548 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELESTA SPA
    Registration Number
    3015077548
    FEI Number
    3015077548
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Arsiero Salvanti 43
    City
    Calenzano Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K213594

    Owner / Operator

    Firm Name
    Elesta SPA
    Operator Number
    10059916
    Address
    Via Baldanzese 17
    City
    Calenzano
    State
    Firenze
    Postal Code
    50041
    Country
    IT
    Correspondent
    Alessia Blundo

    US Agent

    Business Name
    CDI MED LLC
    Contact Name
    Carlos Andres Perez
    Address
    2801 NW 74TH AVE, SUITE202
    City
    Miami
    State
    FL
    ZIP
    33122
    Country
    US
    Email
    [email protected]
    Phone
    954 5040432

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Echolaser X4

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility