BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HEALITE II System

    Reg #: 3023706404 · FEI: 3023706404 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Lutronic Corporation
    Registration Number
    3023706404
    FEI Number
    3023706404
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    56 Cheombok-ro, Dong-gu
    City
    Daegu Gyeongbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K113668

    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
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    HEALITE II System

    Establishment Types

    Manufacture Medical Device