Device Description : The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to takephotographs of the anterior segment of the eye, table mounted and AC powered. The systemis based on the Scheimpflug Principle for Slit Image photography. The device consists of ameasurement 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 measuringsystem offers the possibility of automatically rotation to get photographs of every part of theeye. The system calculates from the photos a 3D-model1 of the eye.
Device Class : 2
Duns Number: 317138956
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to takephotographs of the anterior segment of the eye, table mounted and AC powered. The systemis based on the Scheimpflug Principle for Slit Image photography. The device consists of ameasurement 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 measuringsystem offers the possibility of automatically rotation to get photographs of every part of theeye. The system calculates from the photos a 3D-model1 of the eye
Device Class : 2
Duns Number: 317138956
Premarket Exempt : No
Prescription Use : Yes
Device Description : The OCULUS Easyfield® has been designed for combined use as ascreening unit with The OCULUS Easyfield® has been designed for combined use as ascreening unit with all associated options for immediate follow-upexamination of suspicious findings. The most common examination gridsand strategies for the central visual field up to 30° can be accessed.The Easyfield® offers pre programmed combinations for often neededexamination routines. For example: Screening 24-2, SPARK Quick,Macula. You can also combine your own routines and then save them asa program.
Device Class : 1
Duns Number: 317138956
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The OCULUS Easyfield® has been designed for combined use as ascreening unit with The OCULUS Easyfield® has been designed for combined use as ascreening unit with all associated options for immediate follow-upexamination of suspicious findings. The most common examination gridsand strategies for the central visual field up to 30° can be accessed.The Easyfield® offers pre programmed combinations for often neededexamination routines. For example: Screening 24-2, SPARK Quick,Macula. You can also combine your own routines and then save them asa program.
Device Class : 1
Duns Number: 317138956
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The PARK 1 combines three measuring functions in one unit.Auto-RefractometerAn i The PARK 1 combines three measuring functions in one unit.Auto-RefractometerAn infrared light source projects measuring light onto the retina of the eyefrom where it is reflected back to the shutter location. Sensitive sensorchips, or CCD cameras now register the deviation of the reflected light fromthe shutter location. The deviation depends on the ametropia. From that, anintegrated microcomputer calculates the ametropia in D, based on thesphere, cylinder and cylinder axis position.1 Measuring ocular / Patient eyepiece 4 Chin rest2 Keratometer ring 5 Marking for the eye height3 Pachycam camera glass coverKeratometerTo determine the curvature of the cornea, a reflected image of the corneais captured by a camera sensor and is measured.The reflection of test marks and of a ring is used as the reflected image.This allows the central radii of the cornea to be determined.PachymeterThe pachymetry principle uses Scheimpflug images of the cornea, whichare analysed by a built-in computer.600 Absolute data points are evaluated with the Scheimpflug image. Themeasuring range lies on a 4 mm slit through the apex.The slit light illuminates a sectional plane from the front surface of the corneato the back surface. The transparent cells of the cornea scatter the slitlight such that the sectional plane appears as if it were self-luminous.This is captured at an angle of 45° through the pupil by a camera, wherebythe image plane of the camera is also tilted 45° to the optical axis of thecamera lens, in order to sharply focus the light-scattering cornea planeonto the image plane of the camera (Scheimpflug image).Thanks to this arrangement, sharp sectional images of the cornea can be attained.
Device Class : 1
Duns Number: 317138956
Premarket Exempt : No
Prescription Use : Yes
Device Description : The OCULUS Keratograph 5M combines the keratometric measuring processwith topogr The OCULUS Keratograph 5M combines the keratometric measuring processwith topographic mapping.Measurement of the corneal surface is done by means of a Placido ringsystem that is reflected off the cornea. These data are analyzed by thecomputer.
Device Class : 1
Duns Number: 317138956
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : While rotating around the eye, the Pentacam® AXL captures Scheimpflugimages of t While rotating around the eye, the Pentacam® AXL captures Scheimpflugimages of the anterior eye segment through varying axes. TheScheimpflug images created during an examination are transmitted tothe connected PC.The axial length of the eye is measured and displayed by interferometry.
Device Class : 2
Duns Number: 317138956
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Corvis® ST is a non-contact tonometer equipped with an opticalPachymetry fun The Corvis® ST is a non-contact tonometer equipped with an opticalPachymetry function.The Corvis® ST measures intraocular pressure without contact with the eyeby applying an air puff to the eye. During the air puff the eye getsilluminated by a 9 mm slit through the apex and a built-in high-speedcamera records the movement of the eye with more than 4000 images persecond.The high-speed camera uses a sequence of 140 Scheimpflug images of thecornea which are analyzed by a built-in computer.Intra ocular pressure is determined by the detection of the applanationmoments of the cornea.
Device Class : 2
Duns Number: 317138956
Premarket Exempt : No
Prescription Use : Yes
Device Description : While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes to evaluate several parameters of the cornea, pupil, anterior chamber and lens. The axial length of the eye is measured and displayed by interferometry. Wavefront measurement uses a Hartmann Shack aberrometer to detect the low and high order aberrations of the entire eye.
Device Class : 2
Duns Number: 317138956
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Myopia Master combines different measuring functions in one unit.The Auto-Re The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry.
Device Class : 2
Duns Number: 317138956
Premarket Exempt : No
Prescription Use : Yes