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The VX650 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: - · Measuring the refraction of the eye giving both lower and higher order aberrations - · Measuring the shape of the cornea - · Retro-illumination imaging of the eye - Measuring the intraocular pressure without contacting the eye for glaucoma evaluation - · Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea - Full cornea thickness map - · Scheimpflug imaging - · Anterior chamber imaging - · Pupil Image - · Image of the cornea relative to the iris - · Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatio agent

The VX650 is based on the VX130 (already cleared 510(k), number K162067) which is a combined wavefront aberrometer, corneal topographer, Scheimpflug pachymeter, non-contact tonometer and cataract screening device in a single platform that contains five different measurement units. The VX650 also contains a non-mydriatic fundus camera for retinal photography. The wavefront aberrometer uses the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the refraction of the eye. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. The Scheimpflug pachymeter measures the thickness of the central cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique, there is also a scanning mode that allows measurement of the whole corneal surface and can provide detailed tomography maps of both corneal surfaces and the corneal thickness. An air puff non-contact tonometer is included for measurement of the intraocular pressure and retro illumination is present for cataract screening. The fundus camera contains an infra-red LED for alignment and focusing and a white LED flash for the photography to give colour images. The fundus image covers an angle of 45° on the retina so a regular image will contain both the macula and the optic nerve. The fundus camera also has a seven-position fixation target to increase the field of view as the patient can fixate in different directions. The device is fully automated and a number of different measurements can be performed by a sinqle command including alignment and focusing. The fundus imaging function is also fully automatic including automatic alignment, focusing and image capture.