BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BIOXEL Fractional CO2 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
    K173359

    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

    BIOXEL Fractional CO2 Laser System IBLAZE Fractional CO2 Laser System

    Establishment Types

    Manufacture Medical Device