BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    ELTECH K-LASER S.R.L.

    Reg #: 3004642415 · FEI: 3004642415 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ELTECH K-LASER S.R.L.
    Registration Number
    3004642415
    FEI Number
    3004642415
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA CASTAGNOLE, 20/H-INTERNO 2
    City
    TREVISO
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K120604

    Owner / Operator

    Firm Name
    ELTECH K-LASER, S.R.L.
    Operator Number
    9067781
    Address
    VIA CASTAGNOLE, 20/H-INTERNO 2, --
    City
    TREVISO
    State
    IT-TV
    Postal Code
    31100
    Country
    IT
    Correspondent
    GIORGIA - ZANATA

    US Agent

    Business Name
    K-LASER USA INC
    Contact Name
    Remco Schmitz
    Address
    345 Inverness Dr S Bldg B
    City
    Englewood
    State
    CO
    ZIP
    80112
    Country
    US
    Email
    [email protected]
    Phone
    617 4559838

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    GIRO ULTRA K-Laser Cube Plus 30 Speciale Live Therapy Plus Speciale Live Therapy GIRO CORE GIRO ELITE K-laser Cube1, K-laser Cube2, K-laser Cube 3, K-laser Cube 4

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)