BEUDAMED
    Product Code: MJP FDA class 3 21 CFR 886.3600

    Lens, Intraocular, Toric Optics

    Ophthalmic

    The Toric Optics Intraocular Lens (IOL) is a surgically implanted lens placed inside the eye following cataract removal or refractive lens exchange, featuring a toric design to correct astigmatism in addition to restoring vision in patients with pre-existing corneal astigmatism. As a Class 3 implantable device under 21 CFR 886.3600, it requires Premarket Approval (PMA) and is reviewed by the Ophthalmic specialty panel. It carries an implant flag given its intraocular placement.

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    510(k)s
    0
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MJP
    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 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.