BEUDAMED
    Product Code: MSI FDA class 3

    Solution, Cleaning / Lubricating, Artificial Eye

    Unknown

    A Cleaning and Lubricating Solution for Artificial Eyes is a sterile preparation used for the cleansing, lubrication, and maintenance of ocular prostheses (artificial eyes), helping to prevent irritation of the surrounding tissue and extend the useful life of the prosthesis. This device is classified as FDA Class 3, the highest risk class, requiring Premarket Approval (PMA) demonstrating safety and effectiveness before marketing. The product code is MSI, with no regulation number currently assigned, and is reviewed under an unspecified specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    MSI
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OP
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K893829 POWERED EYE WASH