BEUDAMED
    Product Code: MMF FDA class 2 21 CFR 886.1120

    Photorefractor

    Ophthalmic

    The Photorefractor is an ophthalmic instrument that uses photographic or video-based techniques to objectively estimate the refractive error of the eye, including myopia, hyperopia, and astigmatism, by analyzing the pattern of light reflected from the retina through the pupil without requiring the patient's subjective responses. Classified as a Class 2 device under 21 CFR 886.1120 within the Ophthalmic specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MMF
    Device Class
    FDA class 2
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K934880 MTI PHOTOSCREENER

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.