BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Secret Duo

    Reg #: 3010363436 · FEI: 3010363436 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CLASSYS INC
    Registration Number
    3010363436
    FEI Number
    3010363436
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9F, 25, Deokcheon-ro 152beon-gil, Manan-gu
    City
    Anyang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K213250

    Owner / Operator

    Firm Name
    CLASSYS INC
    Operator Number
    10051595
    Address
    CLASSYS, 208, Teheran-ro, Gangnam-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    06220
    Country
    KR
    Correspondent
    James Lim

    US Agent

    Business Name
    Elexes Medical Consulting LLC
    Contact Name
    Dana S
    Address
    218 Eclipse Drive Bordentown, NJ US
    City
    Bordentown
    State
    NJ
    ZIP
    08505
    Country
    US
    Email
    [email protected]
    Phone
    732 6475105 ext. 1

    Products

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

    Proprietary Names

    Secret Duo

    Establishment Types

    Manufacture Medical Device