BEUDAMED
    Product Code: MTA FDA class 3

    Lens, Intraocular, Phakic

    Unknown

    A Phakic Intraocular Lens is a surgically implanted optical lens placed inside the eye in front of the natural crystalline lens, intended to correct significant refractive errors such as high myopia or hyperopia in patients who are not candidates for corneal refractive surgery, while preserving the natural lens. This device is classified as FDA Class 3, requiring Premarket Approval (PMA) demonstrating safety and effectiveness, and is an implant. The product code is MTA with no regulation number currently assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

    Research product code MTA in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    MTA
    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

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.