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The VS Tabletop Tonometer is a digital tonometer intended to measure intraocular pressure of the human eye.

The VS Tabletop Tonometer (VS TT) is a non-contact, table-top tonometer used to measure intraocular pressure of the eye. The tonometer is based on the previously cleared MiiS tonometer, the Horus Scope DPT 100 (K181260). The core technology element of the VS TT is the air puff module, which is equivalent to the air puff module used in the DPT 100 predicate device. The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same. The main technological difference between the VS TT and the predicate DPT 100 is that the VS TT features an auto-alignment system that automatically brings the air puff module within a positional range with respect to the patient's cornea such that the air puff module is able to perform the IOP measurement. The auto-alignment system of the subject device performs the same pre-positioning adjustments that are performed manually by clinical staff with the DPT 100. Hence, the consequence of these design modifications is that a clinical staff member is not required to perform an intermediary, non-critical step in measurement acquisition. The VS TT device is intended to be used by patients in doctor's office with the assistance from eye care professional. Patients are first trained on how to use the device. The VS TT measures IOP in the range of 7-55 mmHg. It contains a graphical user interface on a color LCD touchscreen display where the IOP results are displayed. The device is powered by a rechargeable lithium-ion battery. It can either be used alone (i.e. not plugged in) or connected to a power adapter.

The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue™ Tablet OR VersaVue™ Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.

VersaVue™ Single-Use Flexible Cystoscope is a single-use, flexible, sterile cystoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected display system (VersaVue™ Tablet OR VersaVue™ Video Box). The working channel provide access for accessories to conduct surgical process. VersaVue™ Tablet is a tablet. The live imaging or snapshot will present directly on the tablet. VersaVue™ Video Box is a standalone imaging transfer system, it can be connected to computer to project live imaging. The function of VersaVueTM Single-Use Flexible Cystoscope is to provide live imaging of the lower urinary tract, including tissue appearance recording, snapshot, vertical flip and horizontal flip.

The ENT Nasopharyngoscope EES 100 is a sterile, single-use, and flexible device intended to be operated with its compatible display (EVS 100) for endoscopic procedures within nasal lumens and upper airway anatomy. The Video Box EVS 100 is intended to provide visualization via the connected tablet. The Nasopharyngoscope is intended for use in a hospital environment. It is designed for adult use.

ENT Nasopharyngoscope and Accessories contain nasopharyngoscope (model name: EES 100) and image transfer system (Video Box, model name: EVS 100A). EES 100 is a single-use, flexible, sterile nasopharyngoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected Video Box (EVS 100A). EVS 100A is attached on a tablet. The live imaging or snapshot will present directly on the tablet. The function of Nasopharyngoscope is to provide live imaging of the nasal tissue, including tissue appearance recording, snapshot, vertical flip and horizontal flip. The device does not provide any instruction for diagnosis nor treatment.

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.

MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of eyeball.

MiiS Horus Scope DPT 100 is a Li-ion battery-powered device. The Li-ion battery is rechargeable. It is a digital portable tonometer used to measure intraocular pressure of eyeball. The device uses a white LED for illumination and capture image. The device has been tested according to the ISO 15004-2 (first edition, 2/15/2007) and been classified as Group I device. The device has a CMOS sensor. The sensor accomplishes a task of capturing light and converting it into electrical signals. The device store images to a SD card and have connectivity towards PC. The device uses an USB 2.0 interface to transfer data or picture to PC when connected. The operation method of the device is described step by step in the attachment A1 "User manual". There is a graphical user interface color TFT display and keypad that is used for making adjustments before and during measure intraocular pressure of eyeball. Its' measure rang is 7-55 mmHg.

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.