BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPTOVUE, INC.

    Reg #: 3005950902 · FEI: 3005950902 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    24
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    OPTOVUE, INC.
    Registration Number
    3005950902
    FEI Number
    3005950902
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    231 Charcot Avenue
    City
    San Jose
    State
    CA
    ZIP
    95131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071250

    Owner / Operator

    Firm Name
    OPTOVUE, INC.
    Operator Number
    9091799
    Address
    231 Charcot Avenue, --
    City
    San Jose
    State
    CA
    Postal Code
    95131
    Country
    US
    Correspondent
    Peter G Sparacio

    Products

    Device Name Product Code
    Tomography, Optical Coherence OBO
    Ophthalmoscope, Ac-Powered HLI
    Topographer, Corneal, Ac-Powered MMQ
    Camera, Ophthalmic, Ac-Powered HKI

    Proprietary Names

    CA (Model: CAM) iVue 100 iVue RTVue XR OCT Avanti with AngioVue Software; or; AngioVue Imaging System AngioVue Imaging System RTVue Cam iVue NR iVue with NDB RTVue Model 100 and 200 iCam 100 iCam 12MP Avanti RTVue 100 RTVue XR OCT RTVue XR RTVue XR OCT Avanti iVue 500 iScan 80 iScan iFusion iFusion 80 iVue 80 SOLIX SOLIX Essential

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device