BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    INFINI Radiofrequency System

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

    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
    K121481

    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
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    INFINI Radiofrequency System

    Establishment Types

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