BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HandyRay-Pro (model LMT-5000)

    Reg #: 3014384451 · FEI: 3014384451 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LAMEDITECH CO., LTD.
    Registration Number
    3014384451
    FEI Number
    3014384451
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #1002, ACE High End Tower 6th, Beotkkot-ro-234, Geumcheon-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K172818

    Owner / Operator

    Firm Name
    LAMEDITECH Co., Ltd.
    Operator Number
    10057401
    Address
    #1002, ACE High End Tower 6th, Beotkkot-ro-234, Geumcheon-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    08513
    Country
    KR
    Correspondent
    Byungchul Park

    US Agent

    Business Name
    Immunostics Inc.
    Contact Name
    Jung Hee Kim
    Address
    38 industrial way east, suite 1
    City
    Eatontown
    State
    NJ
    ZIP
    07724
    Country
    US
    Email
    [email protected]
    Phone
    732 9180770

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    HandyRay-Pro (model LMT-5000) HandyRay (model LMT-3000) HandyRay-Lite (model LMT-1000)

    Establishment Types

    Manufacture Medical Device