BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    COLORMAX PLUS Q-Switched Nd:YAG Laser System

    Reg #: 3014253920 · FEI: 3014253920 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AMI INC.
    Registration Number
    3014253920
    FEI Number
    3014253920
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RM.1407, 1408, 1409, SJ Techno Ville, 278, Beotkkot-ro,
    City
    Geumcheon-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K172908

    Owner / Operator

    Firm Name
    AMI INC.
    Operator Number
    10056500
    Address
    RM.1407,1408,1409, SJ Techno Ville,, 278, Beotkkot-ro, Geumcheon-gu
    City
    Seoul
    State
    KR-NOTA
    Postal Code
    08511
    Country
    KR

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    COLORMAX PLUS Q-Switched Nd:YAG Laser System Q-MASTER Q-Switched Nd:YAG Laser System

    Establishment Types

    Manufacture Medical Device