BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pentacam AXL

    Reg #: 3033566 · FEI: 3002785343 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OCULUS, INC.
    Registration Number
    3033566
    FEI Number
    3002785343
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17721 59th Avenue NE
    City
    Arlington
    State
    WA
    ZIP
    98223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152311

    Owner / Operator

    Firm Name
    OCULUS OPTIKGERATE GMBH
    Operator Number
    8010318
    Address
    Muenchholzhaeuser Str. 29, --
    City
    WETZLAR
    State
    DE-NOTA
    Postal Code
    D-35582
    Country
    DE

    Products

    Device Name Product Code
    Device, Analysis, Anterior Segment MXK

    Proprietary Names

    Pentacam AXL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198