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510(k) Data Aggregation

    K Number
    K030393
    Device Name
    OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
    Manufacturer
    HAAG-STREIT HOLDING AG
    Date Cleared
    2003-09-25

    (232 days)

    Product Code
    MXK
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAAG-STREIT HOLDING AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OLCR Pachymeter Pachy-01 SL is a device used with slit-lamp systems to measure corneal thickness. The OLCR Pachy-01 SL includes the functional capability to perform calculations of residual stroma thickness and correction to intraocular pressure values from user input.
    Device Description
    The Haag-Streit OLCR Pachymeter Pachy-01 SL is a device used with slit-lamp biomicroscopes to measure corneal thickness without eye contact. The Pachymeter is an add-on to Haag-Streit slit-lamps, including the BC 900, and those of other manufacturers marketed in the US. The Haag-Streit slit lamp and pachymeter provide ophthalmology specialists with the means of performing ocular measurements without contact, anesthesia, and external indentation of the ocular surface. The Haag-Streit pachymeter system allows for instantaneous, precise/reproducible and real time measurements. The OLCR Pachymeter consists of a base unit, a light-delivery instrument and a user touch pad. The Pachymeter's Base unit generates a computer-controlled laser/light signal that is delivered through a fiber-optic coupler cable and emitted from a light-delivery instrument attached to the slit-lamp biomicroscope. The instrument emits light in the visible and infrared spectral regions within limit values specified by the ISO standard for ophthalmic instruments, ISO EN 15004. The instrument provides two laser exit locations; a location for the axial aiming laser and the measuring laser and a location for the lower aiming laser. The OLCR Pachymeter functions and assessment are user-controlled by means of a touch screen pad.
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