BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Lutronic Corporation

    Reg #: 3013789508 · FEI: 3013789508 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Lutronic Corporation
    Registration Number
    3013789508
    FEI Number
    3013789508
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Poskom Tower, 3F, 227, Sowon-ro, Deogyang-gu
    City
    Goyang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K251327

    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
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Powered Laser Surgical Instrument GEX
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    XERF DENTA III+ ECO2 PLUS DENTA III HEALITE II eCO2 3D INIFINI CLARITY II Laser System PICOPLUS Laser System MOSAIC 3D HOLLYWOOD SPECTRA DermaV Laser System LaseMD Ultra LUTRONIC GENIUS LaseMD

    Establishment Types

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