BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SMAXEL Fractional CO2 Laser System (formally MX-7000 MICROXEL)

    Reg #: 3012639861 · FEI: 3012639861 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    IDS LTD
    Registration Number
    3012639861
    FEI Number
    3012639861
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    194 Simgung-Ro, Gwangtan-Myeon
    City
    Paju Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K180036

    Owner / Operator

    Firm Name
    IDS LTD
    Operator Number
    10053355
    Address
    194, Simgung-ro, Gwangtan-myeon
    City
    Paju-si
    State
    Gyeonggi
    Postal Code
    10952
    Country
    KR

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    SMAXEL Fractional CO2 Laser System (formally MX-7000 MICROXEL)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device