BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    iStent infinite Trabecular Micro-Bypass System Model iS3

    Reg #: 3015217553 · FEI: 3015217553 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AOMI PRECISION CO. LTD.
    Registration Number
    3015217553
    FEI Number
    3015217553
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    787, SHIMOMAGARIDORI, MINAMI-KU
    City
    NIIGATA
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K220032

    Owner / Operator

    Firm Name
    AOMI PRECISION CO. LTD.
    Operator Number
    10088131
    Address
    787, SHIMOMAGARIDORI, MINAMI-KU
    City
    NIIGATA
    State
    JP-15
    Postal Code
    950-1301
    Country
    JP

    US Agent

    Business Name
    Advanced Micro Precision, LLC.
    Contact Name
    Tora Hoppe
    Address
    9591 Irvine Center Dr
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    562 2019534

    Products

    Device Name Product Code
    Implant, Eye Valve KYF

    Proprietary Names

    iStent infinite Trabecular Micro-Bypass System Model iS3

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)