BEUDAMED
    Product Code: MFK FDA class 3 21 CFR 886.3600

    Lens, Multifocal Intraocular

    Ophthalmic

    The multifocal intraocular lens (IOL) is a surgically implanted ophthalmic device placed inside the eye to replace the natural crystalline lens after cataract extraction, designed with multiple focal zones to provide both near and distance vision without spectacles. It is classified as FDA Class III under 21 CFR 886.3600 within the Ophthalmic specialty, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MFK and it carries an implant flag reflecting its permanent intraocular placement. It does not sustain life.

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    510(k)s
    0
    FEI Numbers
    18
    Registration Numbers
    18
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MFK
    Device Class
    FDA class 3
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    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 18 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.