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510(k) Data Aggregation

    K Number
    K201724
    Device Name
    Pentacam AXL Wave
    Manufacturer
    OCULUS Optikgerate GmbH
    Date Cleared
    2020-10-21

    (120 days)

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

    OCULUS Optikgerate GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pentacam AXL Wave is intended to image the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens. It is indicated for the evaluation of - corneal shape, - condition of the lens (opaque crystalline lens), - the anterior chamber angle, - anterior chamber depth, - the volume of the anterior chamber, - anterior or posterior cortical opacity, - the location of cataracts using cross slit imaging with densitometry, - corneal thickness, - axial length, - white-to-white distance. - optical aberrations of the eye, - and retroillumination imaging. The Pentacam AXL Wave also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
    Device Description
    The Pentacam AXL Wave is intended to image the anterior segment of the eye to measure eye components, such as corneal thickness, anterior chamber depth, corneal cylinder, corneal cylinder axis and white-to-white-distance. The axial length of the eye can be measured by a built-in interferometer. An also integrated aberrometer can determine the optical aberrations of the eye. By using retroillumination imaging, the back-lit eye can be observed. The measured parameters can be used by physicians to calculate the power of the intraocular lens (IOL) implanted during a cataract surgery. While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to a connected PC. Scheimpflug images can be captured within maximum of two seconds. Up to 138,000 genuine height values are measured and analyzed from the Scheimpflug images. The Scheimpflug images are the basis for the height data which are used to calculate a mathematical 3D model of the anterior eye segment. The mathematical 3D model, corrected for eye movements, provides the basis for all subsequent analysis. The axial length of the eye is measured by interferometry measurements are done by a common Hartmann-Shack-Aberrometer. The retroillumination works similar to the illumination method of slit-lamps.
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    K Number
    K152311
    Device Name
    Pentacam AXL
    Manufacturer
    OCULUS OPTIKGERATE GMBH
    Date Cleared
    2016-01-20

    (159 days)

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

    OCULUS OPTIKGERATE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pentacam® is designed to take photos of the anterior segment of the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - · corneal shape, - · analyze condition of the lens (opaque crystalline lens), - · analyze the anterior chamber angle, - · analyze anterior chamber depth, - · analyze the volume of the anterior chamber, - · analyze anterior or posterior cortical opacity. - · analyze the location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry, - · corneal thickness, - · axial length, - · white-to-white distance. The Pentacam® AXL also performs calculations to assist physicians in determining the power of the intractular lens for implantation.
    Device Description
    The Pentacam AXL is designed to take photos of the anterior segment of the eye to measures eye components such as Axial length, Corneal thickness, Anterior chamber depth, Corneal curvature, Corneal cylinder, Corneal cylinder axis and White-to-white-distance. The measured parameters can be used by physicians to calculate the power of the intraocular lens (IOL) implanted during a cataract surgery. While rotating around the eye. the Pentacam® AXL captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. The axial length of the eye is measured by interferometry. Scheimpflug images can be captured within maximum two seconds. Up to 138,000 genuine height values are measured and analyzed from the Scheimpflug images. The Scheimpflug images are the basis for the height data which are used to calculate a mathematical 3D model of the anterior eye segment. The mathematical 3D model, corrected for eye movements, provides the basis for all subsequent analysis.
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    K Number
    K113066
    Device Name
    CORVIS ST
    Manufacturer
    OCULUS OPTIKGERATE GMBH
    Date Cleared
    2012-11-08

    (388 days)

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

    OCULUS OPTIKGERATE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Corvis ST is intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism. In addition, the Corvis ST is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea.
    Device Description
    The Corvis ST performs the following two functions: Tonometry and Pachymetry. The Corvis ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. The eye is illuminated and during the air puff, a high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera analyzes a sequence of 140 Scheimpflug images of the cornea to determine intra-ocular pressure. The Corvis ST measure corneal thickness and shape based on sectional images when the cornea is not influenced by the air puff. The pachymetry measurements of the Corvis ST and the cleared Oculus predicate use the same image processing routine for analysis to obtain corneal thickness measurements. Tonometry and pachymetry functions can be performed during the same evaluation or separately.
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    K Number
    K073508
    Device Name
    PARKONE
    Manufacturer
    OCULUS OPTIKGERATE GMBH
    Date Cleared
    2008-09-11

    (273 days)

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

    OCULUS OPTIKGERATE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PARK 1 is designed to photograph the eye and take Scheimpflug images of the anterior segment to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea. The implanted Ophthalmic Refractometer measures the refractive power of the eye.
    Device Description
    The PARK 1 is a non-invasive, diagnostic system created to: - take photos of the anterior segment of the eye - measure the refractive power of the eye - measure the central corneal K-values. The device is stationary and AC powered. The PARK 1: - is based on the Scheimpflug Principle for Slit Image photography. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The device takes a series of images of the anterior segment of the eye from one fixed location (180°) and analyses one, selected by software - has a real keratometer to measure directly the central keratometer values as per definition in the 3.1mm ring. - includes an Ophthalmic Refractometer to measure the refractive power of the eye (21CFR886.1760) The device consists of a measurement unit, built in CPU, head and chin rest and an external power supply.
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    K Number
    K041841
    Device Name
    PACHYCAM
    Manufacturer
    OCULUS OPTIKGERATE GMBH
    Date Cleared
    2005-01-28

    (204 days)

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

    OCULUS OPTIKGERATE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pachycam is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea.
    Device Description
    The Pachycam is a non-invasive, diagnostic system created to take photos of the anterior segment of the eye, portable and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The device takes a series of the anterior segment of the eye from one fixed location (180°) and analyses one, selected by software.
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    K Number
    K030719
    Device Name
    PENTACAM SCHEIMPFLUG CAMERA
    Manufacturer
    OCULUS OPTIKGERATE GMBH
    Date Cleared
    2003-09-16

    (193 days)

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

    OCULUS OPTIKGERATE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pentacam is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - • corneal shape, - analyse condition of the lens (opaque crystalline lens), ● - analyse the anterior chamber angle, ● - analyse anterior chamber depth, . - analyse the volume of the anterior chamber, . - . analyse anterior or posterior cortical opacity, - analyse the location of cataracts (nuclear, subcapsular and or cortical), using cross . slit imaging with densitometry, - corneal thickness. ●
    Device Description
    The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-modell of the eye.
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