LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023676
    Device Name
    APPLANATION TONOMETER
    Manufacturer
    OPTILASA S.L.
    Date Cleared
    2003-04-24

    (174 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTILASA S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a manual tonometer intended to measure intraocular pressure (IOP) by applying a know force to the qlobal of the eye. The device measures the IOP by applanation (application of a small measuring prism to the cornea).The device is intended for use in the diagnosis of glaucoma.
    Device Description
    The device is a manual tonometer intended to measure intraocular pressure (IOP) by applying a know force to the qlobal of the eye. The device measures the IOP by applanation (application of a small measuring prism to the cornea).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1