BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    iSert preloaded IOL System (Model No. 231)

    Reg #: 3008344633 · FEI: 3008344633 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HOYA SURGICAL RESEARCH CENTER
    Registration Number
    3008344633
    FEI Number
    3008344633
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Helios II Bldg ,3F 1-12-11, Funado, Itabashi-ku
    City
    Tokyo
    Country
    JP

    Regulatory Submissions

    PMA Number
    P080004

    Owner / Operator

    Firm Name
    Hoya Surgical Research Center
    Operator Number
    10032157
    Address
    6-10-1 Nishi-Shinjuku, Shinjuku-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    160-8347
    Country
    JP
    Correspondent
    Toru Yoshitomi

    US Agent

    Business Name
    Hoya Surgical Optics
    Contact Name
    Rekha Janarthanan
    Address
    110 Progress Ave., Suite 175
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 8420193

    Products

    Device Name Product Code
    Intraocular Lens HQL

    Proprietary Names

    iSert preloaded IOL System (Model No. 231) iSert preloaded IOL System (Model No. 251) iSert preloaded IOL System (Model No. 230) iSert preloaded IOL System (Model No. 250) iSymm IOL (Model FY-60AD) iSymm IOL (Model FC-60AD) IPure B3PY IPure B3PC IPure B1PY IPure B1PC

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility