BEUDAMED
    Product Code: POE FDA class 3 21 CFR 886.3600

    Extended Depth Of Focus Intraocular Lens

    Ophthalmic

    The Extended Depth Of Focus Intraocular Lens (product code POE) is a Class 3 ophthalmic device intended to be implanted to replace the natural lens of an eye, regulated under 886.3600. Class 3 classification requires Premarket Approval (PMA). The device is flagged as an implant and falls under the ophthalmic medical specialty.

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    510(k)s
    0
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    POE
    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

    Definition

    Intended to be implanted to replace the natural lens of an eye.

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.