BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GentleMax Pro Plus

    Reg #: 1226005 · FEI: 1000623228 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PIONEER OPTICS CO.
    Registration Number
    1226005
    FEI Number
    1000623228
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20 Connecticut South Dr
    City
    East Granby
    State
    CT
    ZIP
    06026
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201111

    Owner / Operator

    Firm Name
    PIONEER OPTICS CO.
    Operator Number
    9035401
    Address
    20 Connecticut South Dr, --
    City
    East Granby
    State
    CT
    Postal Code
    06026
    Country
    US
    Correspondent
    RONALD E HILLE

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    GentleMax Pro Plus

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)