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510(k) Data Aggregation

    K Number
    K042099
    Device Name
    TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
    Date Cleared
    2004-12-10

    (128 days)

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

    RETINAPHARMA TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TonoPach Ultrasonic Tonometer/Pachymeter Model P-201 is a diagnostic instrument that is intended for use in the measurement of both intraocular pressure and corneal thickness. It is intended for use during or following surgery and as a screening, monitoring or diagnostic aid in patients with normal, disease-induced or surgically altered anatomy, or in glaucoma suspects under current therapeutic guidelines.
    Device Description
    The TonoPach is a portable, battery operated, handheld ophthalmic instrument which measures both intraocular pressure (IOP) and corneal thickness (CT) simultaneously and at the same locus on the cornea. The device uses the principles of applanation pneumatometery to measure IOP and the principles of reflection pulsed ultrasound pachymetry to measure CT. The system is comprised of the TonoPach electronics, transducer handpiece, protective membranes and optionally, a foot pedal.
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