BEUDAMED
    FDA Registration Active 🇨🇳 China

    CO2-2B Galaxy CO2 Laser System

    Reg #: 3005450614 · FEI: 3005450614 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Beijing Toplaser Technology Co., Ltd.
    Registration Number
    3005450614
    FEI Number
    3005450614
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    East 3rd Floor, Building M7, No.1, Jiuxianqiao East Road, Chaoyang District
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K133915

    Owner / Operator

    Firm Name
    Beijing Toplaser Technology Co., Ltd.
    Operator Number
    10032897
    Address
    East 3rd Floor, Building M7. No.1, Jiuxianqiao East Road, Chaoyang District
    City
    Beijing
    State
    CN-BJ
    Postal Code
    100016
    Country
    CN
    Correspondent
    XiaoSong Zhang

    US Agent

    Business Name
    CLARSON CHEN
    Contact Name
    CHEN CHEN
    Address
    98 E Broadway Suit 309
    City
    New York
    State
    NY
    ZIP
    10002
    Country
    US
    Email
    [email protected]
    Phone
    917 8921113

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    CO2-2B Galaxy CO2 Laser System

    Establishment Types

    Manufacture Medical Device