BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Powered laser surgical instrument

    Reg #: 3006695864 · FEI: 3006695864 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    AMO Manufacturing USA, LLC
    Registration Number
    3006695864
    FEI Number
    3006695864
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    510 Cottonwood Drive
    City
    Milpitas
    State
    CA
    ZIP
    95035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113151

    Owner / Operator

    Firm Name
    Johnson & Johnson Surgical Vision, Inc.
    Operator Number
    10053607
    Address
    31 Technology Dr., Suite 200
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Keratome, Ac-Powered HNO

    Proprietary Names

    Powered laser surgical instrument Keratome, ac-powered

    Establishment Types

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