BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ELEMENT-TL

    Reg #: 3014980477 · FEI: 3014980477 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELEMENIC CO., LTD.
    Registration Number
    3014980477
    FEI Number
    3014980477
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3rd, 35, Woljeong-ro 20-gil, Gangseo-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K180224

    Owner / Operator

    Firm Name
    ELEMENIC Co., Ltd.
    Operator Number
    10059032
    Address
    3rd, 35, Woljeong-ro 20-gil, Gangseo-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    07775
    Country
    KR
    Correspondent
    Ki Duck Choi

    US Agent

    Business Name
    Plus Global
    Contact Name
    Peter Chung
    Address
    300 Atwood St
    City
    Pittsburgh
    State
    PA
    ZIP
    15213
    Country
    US
    Email
    [email protected]
    Phone
    412 6873976

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    ELEMENT-TL

    Establishment Types

    Manufacture Medical Device