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The HP-OCT™ instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of the posterior segment of the eye.

The Cylite Hyperparallel Optical Coherence Tomographer (HP-OCT) is an ophthalmic OCT system, intended to assist ophthalmic professionals in the diagnosis of ophthalmic conditions via non-contact imaging of the posterior segment. OCT imaging is accomplished in the HP-OCT instrument using a micro-lens array to separate the illumination from a super-luminescent diode (SLD) source into an array of parallel beamlets. The beamlet array is then projected simultaneously onto the eye. Each of the individual beamlets is equivalent to a single beam of an SD-OCT (Spectral Domain OCT) system. Each beamlet generates a spectral interferogram, equivalent to a single SD-OCT interferogram, which is processed to produce an individual A-scan. A set of 1008 parallel, SD-OCT type A-scans is thus acquired for each frame of the CMOS sensor, and multiple frames can be acquired to create dense volume images. The HP-OCT instrument is supplied with an exchangeable lens which supports OCT imaging of the posterior segment. The HP-OCT instrument is operated from the Cylite Focus softwarethat runs from a Windows 10 personal computer (PC) supplied by the user. The PC hosts the HP-OCT Capture and Focus Review software and connects to the HP-OCT instrument via a USB 3.0/3.1 cable. From the PC/software, the user employs the PC monitor, keyboard and mouse to interact with the HP-OCT instrument to perform instrument alignment, preview images, capture images, save or load image or patient data, review images, and manage patient data.

KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The KOWA SL-19 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye. Illumination light that emitted from a white light source is applied to the eyeball, Refractive media, Eye Anatomy, Ocular Adnexa, Iris, etc. are magnified and observed with a binocular microscope. Fluorescence of the cornea, conjunctiva, etc. can be observed by irradiating background illumination light and irradiating blue illumination light with a built-in light source. The background White LED function is added to the KOWA SL-19. The blue filter with white LED for the predicated device is removed, and this function is replaced by blue LED for the KOWA SL-19. Duration of illumination is lengthened from 140 min to 360 min from predicate device to the KOWA SL-19 due to replace the battery type from AAA battery to AA battery.

MiiS Horus Eye Anterior Camera is a digital hand-held slit lamp system indicated for non- invasive illumination, magnification, visualization and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area.

MiiS Horus Eye Anterior Camera is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualize and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. It is a Li-ion battery-powered optical device. It brings more complete medical records about the static photos as well as the dynamic videos. MiiS Horus Eye Anterior Camera has an LED light source with visible white light. The device is designed with high-resolution lens and 5M pixels CMOS Sensor, faithful rendering color of the anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. The device can store pictures or videos in memory card, or via the USB, Wi-Fi and Bluetooth transfer pictures or videos to a computer. In addition to rendering images in the 3.5-inch full color TFT-LCD, through the HDMI output, you can connect the device to the big screen (TV, LCD screen) showing the pictures or videos. MiiS Horus Eye Anterior Camera includes two models. The first model consists of control unit DSC 300 and lens unit DEA 200. The second model consists of control unit DSC 300P and lens unit DEA 200P. Either auto or manual focus can be used in first model while only manual focus is used in the second model. The control unit DSC 300 includes a cover glass while DSC 300P does not. The contact rim in lens unit DEA 200 is different from that in DEA 200P.

The Chongqing Sunkingdom Slit Lamp LS-1A, LS-1B are AC --- powered slit lamp Biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

Sunkingdom slit lamp LS-1A, LS-1B are an AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affects the structural properties of the anterior eye segment. An AC-powered Slit lamp Bio-microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. Components: The optical body, movement mechanism, illumination system, portable handle, power supply.

The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures: - · Lens thickness - · Corneal curvature and thickness - · Axial length - · Anterior chamber depth - · Pupil diameter - · White-to-white distance (WTW)

The IOLMaster 700 is a non-invasive optical biometry instrument for visualization and measurement of ocular structures. The IOLMaster 700 is the latest generation device in the IOLMaster series. The version of the IOLMaster 700 that is the subject of this submission is a modified version of the IOLMaster 700 cleared under K170171.

The KH Ophthalmic Slit-lamp Microscope is an AC-powered slitlamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The KH Ophthalmic Slitlamp Microscope is composed of the following components: microscope unit, illumination unit, base unit, chinrest, and table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.

MiiS Horus+ Scope DEA 200 is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualization and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area.

MiiS Horus* Scope DEA 200 is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualize and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. It is a Li-ion battery-powered optical device. It brings more complete medical records about the static photos as well as the dynamic videos. MiiS Horus* Scope DEA 200 has an LED light source with visible white light. The device is designed with high-resolution lens and 5M pixels CMOS Sensor, faithful rendering color of the anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. The device can store pictures or videos in SD memory card, or via the USB transfer pictures or videos to a computer. In addition to rendering images in the 3.5-inch full color TFT-LCD, through the AV output, you can connect the device to the big screen (TV, LCD screen) showing the pictures or videos. Below includes a summary of the technical information used in the substantial equivalence comparison. It is more efficient and suitable for many different applications, such as electronic filing.

Portable Slit Lamp Microscope Model KJ5S is intended for use in the anterior and posterior segment of the eye.

The Portable Slit Lamp Microscope is a hand held converging stereomicroscope system powered by rechargeable batteries.

An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The SL 220 can be used in performing a wide range of conventional eye care applications. It is used for ophthalmic observation of structural properties of the eye. The illumination can be adjusted from slit type illumination to a full-field type illumination by beam forming elements. The instrument is primarily used by ophthalmologists, opticians and optometrists.

The SLIT LAMP SL-2000 is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. This device is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light. The SL-2000 comprises the main unit that incorporates the microscope unit, illumination unit, base plate unit, and power supply box.