BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iSert Preloaded IOL System (Model 250)

    Reg #: 3006723646 · FEI: 3006723646 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HOYA SURGICAL OPTICS, INC.
    Registration Number
    3006723646
    FEI Number
    3006723646
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    110 Progress Ave., Suite 175
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    PMA Number
    P080004

    Owner / Operator

    Firm Name
    Hoya Surgical Optics, Inc.
    Operator Number
    10026397
    Address
    110 Progress Ave., Suite 175
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Rekha Janarthanan

    Products

    Device Name Product Code
    Intraocular Lens HQL

    Proprietary Names

    iSert Preloaded IOL System (Model 250) iSert Preloaded IOL System (Model 251) iSert Preloaded IOL System (Model PC-60AD) PreVue Y PreVue C IPure B1PC iSymm IOL (Model FC-60AD) IPure B3PC iSpheric IOL (Model YA-60BBR) IPure B1PY IPure B3PY iSymm IOL (Model FY-60AD) iSert Preloaded IOL System (Model PY-60R) iSpheric IOL (Model YA-60BB) iSert Preloaded IOL System (Model No. 231) iSert Preloaded IOL System (Model PY-60AD) iSert Preloaded IOL System (Model No. 230)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198