BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENER8

    Reg #: 3012157621 · FEI: 3012157621 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GENER8
    Registration Number
    3012157621
    FEI Number
    3012157621
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2560 Junction Avenue
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071687

    Owner / Operator

    Firm Name
    Gener8
    Operator Number
    10059512
    Address
    2560 Junction Avenue
    City
    San Jose
    State
    CA
    Postal Code
    95134
    Country
    US

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)