BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DENTA III Laser System

    Reg #: 3013789508 · FEI: 3013789508 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Lutronic Corporation
    Registration Number
    3013789508
    FEI Number
    3013789508
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Poskom Tower, 3F, 227, Sowon-ro, Deogyang-gu
    City
    Goyang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K100610

    Owner / Operator

    Firm Name
    Lutronic Aesthetics, Inc.
    Operator Number
    9058403
    Address
    3/5 Carlisle Road
    City
    Westford
    State
    MA
    Postal Code
    01886
    Country
    US
    Correspondent
    Sean Reynolds

    US Agent

    Business Name
    LUTRONIC AESTHETICS, INC.
    Contact Name
    Sean Reynolds
    Address
    3/5 Carlisle Road
    City
    Westford
    State
    MA
    ZIP
    01886
    Country
    US
    Email
    [email protected]
    Phone
    978 8429864

    Products

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

    Proprietary Names

    DENTA III Laser System eCO2 Plus Laser System DENTA III+ Laser System SP III Laser System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device