BEUDAMED
    Product Code: MUW FDA class 2 21 CFR 886.5916

    Lens, Contact (Orthokeratology)

    Ophthalmic

    An Orthokeratology Contact Lens is a rigid gas-permeable contact lens specifically designed and fitted to temporarily reshape the corneal surface overnight, reducing or eliminating refractive errors such as myopia so that patients can see clearly during the day without glasses or contact lenses. It is FDA Class 2, requiring 510(k) clearance, with product code MUW under 21 CFR 886.5916 in the Ophthalmic specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    6
    FEI Numbers
    17
    Registration Numbers
    17
    Unique Applicants
    5
    Years Active
    21

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    Basic Information

    Product Code
    MUW
    Device Class
    FDA class 2
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K183200 iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
    K160859 OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
    K010109 FLUOROPERM 151-OK, PARAGON HDS 100-OK
    K003933 BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
    K000224 FLUROPERM 60-OK, PARAGON HDS-OK
    K973697 AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY

    FEI Numbers

    This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.