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510(k) Data Aggregation

    K Number
    K071183
    Device Name
    ALLEGRO OCULYZER
    Manufacturer
    Date Cleared
    2007-07-20

    (81 days)

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

    WAVELIGHT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ALLEGRO Oculyzer is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber and the lens of the eye. To evaluate: - . Corneal shape - . Analyze condition of the lens (opaque crystalline lens) - Analyze the anterior chamber angle ● - Analyze the anterior chamber depth - Analyze he volume of the anterior chamber ● - Analyze the anterior and posterior cortical opacity . - Analyze the location of the cataracts (nuclear, subcapsular and or cortical), using cross-lit . images with densitometry - Corneal thickness .
    Device Description
    The ALLEGRO Oculyzer Scheimpflug Camera is based on the Scheimpflug principle for slit lamp photography. The system is table mounted onloing powered by an external power supply. The system contains (a) measuring devices including: - illumination unit with LED's, 475nm wavelength UV-free to illuminate the . anterior segment of the eye, - a CCD-Camera unit to take the Scheimpflug Images, . - a CCD-Camera unit in the center for the fixation monitoring and internal . correction, - a optical lens system to project the slit, . - two infrared LED's to illuminate the pupil for fixation monitoring. . (b) electrical devices, including: - a memory board and a CPU and which stores and analyses the taken . images. - a power supply board which prepares and controls the electrical conditions of . the ALLEGRO Oculyzer Scheimpflug system - an electric motor for rotating . - a communication board for transferring the images to external standard high . speed PC's (part of the device) All the mentioned parts are mounted internal the system and the housing around separates this parts from any external illegal operation. The measurement can be done in two different ways, depending of what you like to evaluate: - (c) Taking photos from one Camera position: The Camera takes pictures from one fixed position as it is already well known from the common Scheimpflug Cameras. The intended use is to get information of the condition of the lens. - (d) Taking photos from several positions: The Camera rotates around the eye and takes up to 50 Scheimpflug Images from several positions. Every single picture has 500 measured true elevation points. So in the summary we get 25.000 measured true elevation points. The Scheimpflug Images taken during the examination are digitalized in the system. All Image Data are transferred to the external PC. When the examination is finished, the PC calculates a three dimensional mathematical model from which all additional information is derived. The intention is to get information about - anterior and posterior surface of the cornea, . - . thickness of the cornea. - chamber angle, volume and depth. .
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