BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HOYA SURGICAL OPTICS, INC.

    Reg #: 3006723646 · FEI: 3006723646 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HOYA SURGICAL OPTICS, INC.
    Registration Number
    3006723646
    FEI Number
    3006723646
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    110 Progress Ave., Suite 175
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081346
    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
    Folders And Injectors, Intraocular Lens (Iol) MSS
    Intraocular Lens HQL

    Proprietary Names

    Hoya-IS Injectors and Cartridges (Cartridge Model No. E1) Hoya-IS Injector and Cardtridges (Model No. ISH001, ISH003) iSert Preloaded IOL System (Model 250) iSert Preloaded IOL System (Model 251) IPure B3PC IPure B1PY iSert Preloaded IOL System (Model PY-60R) IPure B3PY iSert Preloaded IOL System (Model PC-60AD) iSymm IOL (Model FC-60AD) IPure B1PC PreVue C iSymm IOL (Model FY-60AD) PreVue Y iSpheric IOL (Model YA-60BBR) iSert Preloaded IOL System (Model PY-60AD) iSpheric IOL (Model YA-60BB) iSert Preloaded IOL System (Model No. 231) iSert Preloaded IOL System (Model No. 230)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198