BEUDAMED
    Product Code: MMQ FDA class 1 21 CFR 886.1350

    Topographer, Corneal, Ac-Powered

    Ophthalmic

    The AC-Powered Corneal Topographer is an instrument powered by alternating current that maps the curvature and shape of the anterior corneal surface using reflected light patterns, providing detailed topographic data used in diagnosing corneal diseases such as keratoconus, planning refractive surgery, and fitting contact lenses. Classified as a Class 1 device under 21 CFR 886.1350 within the Ophthalmic specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

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    510(k)s
    5
    FEI Numbers
    33
    Registration Numbers
    33
    Unique Applicants
    5
    Years Active
    3

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    Basic Information

    Product Code
    MMQ
    Device Class
    FDA class 1
    Regulation Number
    886.1350
    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 5 510(k) clearances via K numbers.

    K Number Device Name
    K981665 SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
    K964702 EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
    K964891 ORBSHOT KERATOMETER
    K963762 CORNEAL TOPOGRAPHER 200
    K950077 INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)

    FEI Numbers

    This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.