BEUDAMED
    Product Code: HJJ FDA class 1 21 CFR 886.1390

    Lens, Fresnel, Flexible, Diagnostic

    Ophthalmic

    The Fresnel Flexible Diagnostic Lens is a thin, flexible ophthalmic lens using Fresnel optic principles, used as an accessory in slit-lamp examinations or attached to existing spectacles for diagnostic evaluation of the posterior eye. It is classified as FDA Class 1, representing the lowest risk category, with no premarket notification required; compliance with general controls is sufficient. The product code is HJJ, regulated under 21 CFR 886.1390, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HJJ
    Device Class
    FDA class 1
    Regulation Number
    886.1390
    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 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.