BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Cynosure Lutronic Technology Corporation

    Reg #: 3033511105 · FEI: 3033511105 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Cynosure Lutronic Technology Corporation
    Registration Number
    3033511105
    FEI Number
    3033511105
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    55 Samwon-Ro, Deogyang
    City
    Goyang Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K183566

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

    Proprietary Names

    PicoSure Workstation CLARITY II Laser System PICOPLUS Laser System MOSAIC 3D HEALITE II PicoSure Pro HOLLYWOOD SPECTRA XERF LaseMD Ultra eCO2 3D DermaV Laser System LUTRONIC GENIUS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device