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MYAH is intended to be used by an eye care professional: - to measure the axial length of the eye in a population age 5 and above - to capture and store digital images of the meibomian glands under near-infrared illumination in adult population. MYAH is not intended to be used in patients with cataracts.

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MY AH is intended for measuring the axial length of the eye in a population age 5 and above and is intended for use under the care of an eye care professional. MYAH is not intended to be used in patients with cataracts.

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The Myopia Master is an interferometer indicated for measuring the axial length of the eye and is intended as an aid to eye care providers.

The OCULUS Myopia Master integrates the axial length measurement function of the cleared OCULUS Pentacam AXL (K152311) into the cleared PARK 1 device (K073508), which is an ocular device that includes Scheimpflug imaging, autorefractometry and keratometry functionalities. The Myopia Master combines the following measuring functions in one unit: Axial length, Auto-Refractometer, Keratometer.

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.

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.

The Galilei G6 Lens Professional) is designed to take images of the anterior segment of the eye, which includes cornea, iris, pupil, anterior chamber, and crystalline lens. To evaluate: - · Corneal shape - · Pachymetry (corneal thickness) - Position of the cornea relative to iris and lens - · Anterior and posterior opacity - · Anterior chamber angle - · Anterior chamber depth - · Volume of the anterior chamber - · White-to-white distance - · Pupil size - · Condition and position of implants (e.g. IOL, phakic IOLs, intracorneal rings) - · Location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry - · Condition of the lens (opaque crystalline lens) - · Lens shape - · Crystalline lens thickness The Galilei G6 Lens Professional is designed to additionally evaluate: • Axial length The Galilei G6 Lens Professional) also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

The Galilei G6 Lens Professional is (in hardware and software) identical to the Galilei G4 Dual Scheimpflug Analyzer but features an additional biometry module (hardware and software) referred to as "EBR Accessory". The Galilei G6 Lens Professional consists of the following functional units: - Measurement Head Container for the cameras, light sources, monitor drivers and electron-● ics. The Placido disk and Dual-Scheimpflug imaging is integrated into the Measurement Head, which performs a 180-degree rotation during data acquisition. - Main Monitor Display and navigation through the software, selection of functions. ● - PC box Container of the power supply and the computer. Periphery (Main monitor, mouse ● and keyboard) is connected directly to the computer. - . Elevation Table - Height-adjustable instrument table with locking wheels. - EBR Accessory Container of the EBR main printed circuit board as well as the optical and ● mechanical components such as a scanner and a partial coherence interferometer used for biometry measurements. Mounted inside the PC box. The GALILE! G6 device takes images of the anterior segment of the eye, which includes the cornea, iris, pupil, limbus, anterior chamber and crystalline lens. Topography and anterior segment tomography are calculated from those images. A pair of slit light images are recorded simultaneously with two cameras placed at opposite sides at an angle of 45°. Due to the Scheimpflug principle, an angled orientation of the camera's sensor allows a sharp focus over the entire image in spite of the 45° recording angle. The images are then analyzed and anterior cornea, anterior lens and iris surfaces are detected. This information is then used to reconstruct a three-dimensional model of the anterior chamber. Twenty (20) concentric rings in the Placido are reflected on the anterior surface of the cornea and recorded by a top-view camera in the center of the measurement head. The sizes and shapes of the recorded rings are used to calculate the curvature of the anterior surface of the eye. Both the Placido and Scheimpflug information are then merged to a single model of the eye. The EBR Accessory enables the Galilei G6 to take an optical A-scan by means of partial coherence interferometry. A beam of partial coherence infrared light is directed along the optical axis into the eye. Whenever it passes a transition between layers with different refractive indices (e.g., corneal surfaces, crystalline lens surfaces, retinal surfaces), a portion of the light is reflected back towards the reflected light is compared to a reference beam passing through a light path of adjustable optical length. The length of the reference arm is varied by a scanner. When the optical lengths of sample arm and reference arm match to within the coherence length of the partial coherence light source, an interference peak is detected and the corresponding layer within the eye is deduced.

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Clamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

The ARGOS is substantially equivalent to the predicate device identified previously: - the ARGOS (Santec Corporation) that was cleared by the FDA on October 2nd, 2015(K150754) as the primary predicate as it has the most similar intended use and characteristics - the IOLMaster 700 (Carl Zeiss Meditec) that was cleared by the FDA on June 29, ● 2015 (K143275, K170171) as an additional (secondary) predicate to support a new feature of reference image capture on the version of ARGOS in this submission. The predicate devices are Class 2 devices to premarket notification, as defined per regulation number 21 CFR 886.1850. In addition, the predicate devices have product codes of MXK(ARGOS), and HJO(IOLMaster700). The version of ARGOS in this submission is a modified version of the Argos cleared under K150754 which is substantially equivalent with regard to intended use, operating principle, function, materials, and energy source. The differences from the predicate ARGOS (K150754) that are subject of this 510(k) submission are: - An additional feature of reference image capture function ● - Labeling change including change in the intended use adding the feature of reference . image capture. - . This image can be transferred to image guided devices in order to support the execution of preoperative plan. The changes described in this submission do not affect how the hardware is used to acquire measurements as a biometer, nor do these changes affect the principle of operation of the device.

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.

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.

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraccular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

Argos is a swept-source based biometer that provides the biometry and keratometry of the eye prior to cataract surgery and aids in the selection of the appropriate IOL. Argos processes 3 OCT images (B-scans) and 3 CMOS camera images per measurement in seconds - reducing procedure time and minimizing patient discomfort. From the OCT images the biometry parameters are evaluated by segmenting the cornea, iris, lens, and retina. The operator can edit the biometry parameters by manual adjustment: Axial length, Corneal thickness, Anterior chamber depth (or aqueous depth), Lens thickness, White-towhite (corneal diameter), Pupil size. The keratometry values: K-values (flattest and steepest meridians), Astigmatism (angle of flattest meridian), are evaluated from the CMOS camera image, in combination with the OCT information. All distance/thickness parameters (Axial length, Corneal thickness, Anterior chamber depth, Lens thickness, White, Pupil size) are simultaneously measured from 2dimensional OCT images. All the boundaries of ocular segments are detected and distances and thicknesses are calculated by taking into account the refractive indices of each medium. Axial length is the distance from the corneal apex to the fovea or, more specifically, to the ILM (Internal Limiting Membrane). The calculation is performed as the sum of the thicknesses (after refraction correction) of the cornea, aqueous humor, lens and vitreous. Corneal thickness is the distance between the anterior and the posterior apexes of the cornea divided by the cornea refractive index (1.375). Aqueous depth is evaluated as the distance between the posterior surface of the cornea and the anterior surface of the lens divided by the refractive index (1.336). Anterior chamber depth is the sum of corneal and aqueous humor distances. Lens thickness is the distance between the anterior and the posterior surfaces of the lens divided by its refractive index (1.410). Pupil size is the lateral distance between the two inner boundaries of the iris region. White-to-white (Corneal diameter) is the lateral distance between the inner boundaries of the cornea-sclera interface. K-values (Radii of flattest and steepest meridians) and Astigmatism are evaluated by the size and distance of the reflected images of the infrared LED ring projected onto the cornea. Safety protocol is well integrated into the device in both hardware and software to ensure the safety of both the patient and the operator. The control program on the computer runs on Windows. The operation panel on the display attached to the PC provides all the functionalities. IOL calculation uses widely recognized formulas; Hoffer Q, Haigis, Holladay1, SRK/T, etc.

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.

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.