BEUDAMED
    Product Code: MWL FDA class 3 21 CFR 886.5916

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    Ophthalmic

    An Extended Wear Rigid Gas Permeable Contact Lens is a contact lens made from oxygen-permeable rigid materials, approved for continuous overnight or extended wear for multiple days, used to correct refractive errors including myopia, hyperopia, and astigmatism. It is classified as FDA Class 3, requiring PMA approval due to the higher risk associated with extended overnight wear, with product code MWL under 21 CFR 886.5916 in the Ophthalmic specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MWL
    Device Class
    FDA class 3
    Regulation Number
    886.5916
    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 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.