BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gemini 810+980 Soft Tissue Laser

    Reg #: 3011877721 · FEI: 3011877721 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AZENA MEDICAL
    Registration Number
    3011877721
    FEI Number
    3011877721
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1777 Botelho Dr Ste 100
    City
    Walnut Creek
    State
    CA
    ZIP
    94596
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152032

    Owner / Operator

    Firm Name
    Azena Medical
    Operator Number
    10051175
    Address
    1777 Bothelo Dr. Suite 100
    City
    Walnut Creek
    State
    CA
    Postal Code
    94596
    Country
    US
    Correspondent
    Lindsay Tilton

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Gemini 810+980 Soft Tissue Laser

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device