BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    LUTRONIC CORPORATION

    Reg #: 3004483538 · FEI: 3004483538 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    LUTRONIC CORPORATION
    Registration Number
    3004483538
    FEI Number
    3004483538
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    219, 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
    Cynosure LLC
    Contact Name
    Sean Reynolds
    Address
    5 Carlisle Rd
    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
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    DENTA III+ ECO2 PLUS DENTA III INIFINI eCO2 3D XERF LaseMD MOSAIC 3D

    Establishment Types

    Manufacture Medical Device