BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)

    K Number: K233516 · Decision May 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    55
    Applicant Total
    9
    Review Days
    182

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
    K Number
    K233516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reichert, Inc.
    Date Received
    November 1, 2023
    Decision Date
    May 1, 2024
    Product Code
    HKY
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HKY Tonometer, Manual

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HKY), ordered by most recent decision date.

    iCare ST500 (TA04)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CATS-L Tonometer™ Prism

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Applanation Tonometer HT-5000

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    iCare IC200

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    iCare HOME2

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CATS®-D Tonometer Prism

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Reichert, Inc.

    K Number Device Name
    K141954 XCEL 455 SLIT LAMP
    K081756 OCULAR RESPONSE ANALYZER
    K071839 SOCT COPERNICUS, MODEL 15205
    K070534 MODIFICATION TO: OCU-FILM TIP COVER
    K063750 XCEL 255 SLIT LAMP
    K061330 PSL PORTABLE SLIT LAMP
    K042831 ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)
    K032799 NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER