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The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.

The CLARUS 700 is an active, software controlled, high resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Auto-fluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Fluorescein Angiography, Stereo External eye and Fluorescein Angiography- Indocyanine green angiography (FA-ICGA). All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina. The CLARUS 700 angiography imaging aids in the visualization of the vascular structures of the retina and the choroid. With a single capture, CLARUS 700 produces a 90º high definition widefield image. Widefield images are automatically merged to achieve a 135º ultra-widefield of view. The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection. The ultra-widefield montage on CLARUS 700 is no longer dependent just on the patient accurately fixating their gaze on the internal fixation. With the ONH detection, the software will find the optic nerve and determine based on the image(s) captured where the patient was gazing at the point of capture. The CLARUS 700 device allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow in-depth analysis of eye health. CLARUS 700 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient, facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live IR Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures. The CLARUS 700 device's principle of operation is Slit Scanning Ophthalmic Camera also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a line of illumination passes through the slit and scans across the retina. A 2D monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging. Fluorescein Angiography images are captured with green LED illumination at a wavelength that stimulates fluorescence of the injected sodium fluorescein dye. The principle of operation of CLARUS 700 has not changed since the previous clearance, K191194. The CLARUS 700 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply. The device hardware is based on the predicate CLARUS 700 (K191194) hardware. The new ICGA imaging mode on the device required the following hardware changes as stated in the summary above: - Lightbox for Infrared (IR) Laser - Modified Slit filter – FA/ICG Slit Excitation Filter – new coating, no change to FA - Modified Turret Filter 1- FA/ICG Dual Band barrier filter – new coating, no change to FA. - Added Turret Filter 2 – Added second filter. Same coating as Turret Filter 1 to eliminate cornea reflex band in ICG images with a different shape. - Added Large Alignment Tool (LAT) - Added ICG Power Meter Tool The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review). The DEVICE software version 1.2 is based on the predicate CLARUS 700 software version 1.0 (K191194). Added capability for DEVICE software version 1.2 include: - **Simultaneous capture of Fluorescein Angiography (FA) + Indocyanine Green Angiography (ICGA)** - **Angiography Movie:** Capture of multiple pictures in sequence, after a single press of a button. Available for FA, ICGA and Simultaneous FA+ICGA. - **Early Treatment Diabetic Retinopathy Study (ETDRS)** – Manual placement of ETDRS grids (7 field ETDRS and Macula ETDRS) over the pictures: - The ETDRS 7-fields grid in CLARUS is a display of the standard 7-fields in Color Fundus Photography used to determine an ETDRS (Early Treatment Diabetic Retinopathy Study) level for patients with Diabetic Retinopathy. These 7-fields in and around the macular region are displayed in one single widefield image according to definitions followed by the gold-standard 7-field images using narrow-field fundus cameras. - The Macular ETDRS grids display assists in the identification of an ETDRS level in nine subfields centered around the fovea. - **ICGA Boost Mode:** user-selectable option for ICGA capture that increase used light to obtain better picture at later phase. - **8 up view:** addition of the possibility to view eight pictures side by side (currently it is only possible to see 1, 2, 4, 16) The CLARUS 700 device meets the requirements of ISO 10940:2009 standard. The device technical specifications are identical to the predicate device.

The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.

The CLARUS™ model 700 is a new addition to the CLARUS product family consisting of existing model 500 (K181444). The CLARUS 700 is an active, software controlled, highresolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Auto-fluorescence with green excitation. Fundus Auto-fluorescence with blue excitation. Fluorescein Angiography, Stereo and External eve. All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina. The CLARUS 700 angiography imaging aids in the visualization of the vascular structures of the retina and the choroid. With a single capture, CLARUS 700 produces a 90° high definition widefield image. Widefield images are automatically merged to achieve a 135° ultra-widefield of view. The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection. The ultra-widefield montage on CLARUS 700 is no longer dependent just on the patient accurately fixating their gaze on the internal fixation. With the ONH detection, the software will find the optic nerve and determine based on the image(s) captured where the patient was gazing at the point of capture. The CLARUS 700 device allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow in-depth analysis of eye health. CLARUS 700 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient. facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live IR Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures. The CLARUS 700 device's principle of operation is Slit Scanning Ophthalmic Camera also referred to as Broad Line Fundus Imaging (BLFI), same as the predicate CLARUS 500 (K181444). During image capture, a line of illumination passes through the slit and scans across the retina. A 2D monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging. Fluorescein Angiography images are captured with green LED illumination at a wavelength that stimulates fluorescence of the injected sodium fluorescein dye. The CLARUS 700 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply. The CLARUS 700 hardware is based off the predicate CLARUS 500 (K181444) hardware. New FA imaging mode on the CLARUS 700 require the below hardware changes: - Added filters to support FA imaging mode . - Updated slim turret and motor with new positions for reliability, angiography filters and ● FPGA code - Updated calibration tool for new turret positions and differentiation - Change to lightbox board for reliability and support higher duty cycle in support of FA imaging - Updated Onyx All-in-one Computer for 32GB RAM and 2TB HDD storage space - Updated belt driven slit for reliability and to support FA imaging mode ● - . Updated camera to support FA imaging mode The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review). The CLARUS software version 1.1 is based off the predicate CLARUS software version 1.0 (K181444). Added image capture modality includes Fluorescein Angiography. Other changes implemented in the software version 1.1 include: - Automated Optic Nerve Head (ONH) detection for montaging ● - Smart (Region of Interest) Focus ● - Auto brightness for FA image series - Calibration software update for DEVICE hardware changes ● - . FORUM/ Other EMR connectivity updates for new FA imaging mode The CLARUS 700 device meets the requirements of ISO 10940:2009 standard. The device technical specifications are identical to the predicate device. The performance specifications relevant to the user are summarized in the Table 1 below.

The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.

The CLARUS™ 500 is an active, software controlled, high-resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Autofluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Stereo and External eye. All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina. With a single capture, CLARUS 500 produces a 90° high definition widefield image. Widefield images are automatically merged to achieve a 135° ultra-widefield view. The technology allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow analysis of eye health. CLARUS 500 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient, facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live Infrared Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures. The CLARUS 500 device's principle of operation is based on Slit Scanning Ophthalmoscope also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a broad line of illumination is scanned across the retina. A monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging. The CLARUS 500 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply. The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review). The CLARUS 500 technical features relevant to the user are: Field of View (FoV), Image Resolution, Pixel Pitch and Focusing Range. The device meets the requirements of ISO 10940:2009 standard. The performance specifications are summarized in the Table 1 below.