BEUDAMED
    Product Code: HKT FDA class 1 21 CFR 886.1655

    Prism, Fresnel, Ophthalmic

    Ophthalmic

    The Ophthalmic Fresnel Prism is a thin, flexible prismatic lens made using Fresnel optic principles, applied to spectacle lenses to displace or redirect a patient's visual field, used in managing diplopia, strabismus, and visual field defects. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HKT, regulated under 21 CFR 886.1655, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    HKT
    Device Class
    FDA class 1
    Regulation Number
    886.1655
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.