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Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]: The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of: · the retina, retinal nerve fiber layer, optic disc, and · the anterior chamber and cornea (when used with the optional anterior segment OCT adapter) and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices. Scanning Laser Ophthalmoscope Mirante [SLO Model]: The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundus. It is indicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments. It is intended to work with compatible NIDEK ophthalmic devices.

The Nidek Mirante is an Optical Coherence Tomography (OCT) system intended for use as a non-invasive imaging device for viewing and measuring ocular tissue structures with micrometer range resolution. The Nidek Mirante is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The Nidek Mirante uses Fourier Domain OCT, a method that involves spectral analysis of the returned light rather than mechanic moving parts in the depth scan. Fourier Domain OCT allows scan speeds about 65 times faster than the mechanical limited Time Domain scan speeds. The Mirante utilizes Fourier spectroscopic imaging a Michelson interferometer. The interfering light of the reference light and the reflected light from the test eye obtained by the Michelson interferometer are spectrally divided by a diffraction grating and the signal is acquired by a line scan camera. The signal is inverse Fourier transformed to obtain the reflection intensity distribution in the depth direction of the patient's eve. The galvano mirror scans the imaging light in the XY direction to obtain a tomographic image. The Mirante includes scanning laser ophthalmoscope (SLO) functions as well as the OCT functions. The SLO component uses a confocal scanning system for image capture. The imaging light emitted from the laser oscillator passes through the hole mirror and enters the patient's eye. The reflected by the hole mirror and the signal is obtained by the detector. A resonant mirror and a galvanometer mirror placed in the imaging optical path scan the imaging light in the XY direction to obtain a flat surface image. The device includes Image Filing Software NAVIS-EX which is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

The OPHTHALMIC YAG LASER SYSTEM YC-200 consists of a slit lamp and the YAG Laser and is indicated for the performance of posterior capsulotomy, posterior membranectomy, pupillary membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.

The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed laser system using a 1,064 nm Q-switched pulsed Nd: YAG laser as the treatment beam source. The system consists of two types, differing only in the available types of laser emission. The two types are collectively referred to as "YC-200" throughout this 510(k). The operation mode(s) available differs depending on the type. | Type name | Model name | Emitted laser (wavelength) | Operation mode available | |------------------|------------|------------------------------------------------|--------------------------| | YC-200 | YC-200 | Nd: YAG laser (1,064 nm) | YAG mode | | YC-200 S<br>Plus | YC-200 | Nd: YAG laser (1,064 nm)<br>SLT laser (532 nm) | YAG mode<br>SLT mode | As shown in the above table, the YC-200 S Plus provides the operator with two treatment modes, YAG mode and SLT mode, whereas the YC-200 type provides the operator with a single treatment mode, YAG mode. In YAG mode, treatment using the YAG treatment beam whose wavelength is 1,064 nm is available. This mode is used mainly for posterior capsulotomy and iridotomy. The 360-degree rotating two-aiming-beam system that separates the YAG aiming beam into two beams is used. The focus position is determined according to the alignment of the beams. In YAG mode, single irradiation mode and burst mode are available. In single mode, one shot of the treatment beam is emitted each time the trigger switch is pressed, whereas in burst mode, two or three shots of the treatment beam are emitted each time the trigger switch is pressed. In YAG mode, the focus shift function to shift the focal points of the YAG treatment beam on the basis of the YAG aiming beam is available. This function allows the operator to shift the focal point of the YAG beam to the posterior chamber side compared to the aiming beam in order to prevent pitting of the intraocular lens. In SLT mode, treatment using the YAG treatment beam whose wavelength is 532 mm is available. This mode is used for selective laser trabeculoplasty. In this mode, a parfocal optical system is used. In the parfocal optical system, the image of an object surface is formed on the target surface. The SLT aiming beam is emitted from the fiber tip (the object surface) so that it appears as a sharply-edged spot on the target surface. The focus position is determined according to the projection status of the beams. In SLT mode, SLT-NAVI assists the operator in surgery by specifying the laser emission positions and sequence before the treatment is available. The progress status of laser treatment is intuitively displayed in real time in the SLT-NAVI area of the main screen based on the premise that the treatment is proceeding as scheduled. The system is mainly comprised of the YC-200 main body that incorporates a laser source, and a slit lamp that is similar to the previously cleared SL-2000 (K163564), a head rest, a control box that controls laser emission, and a connector box. To use the YC-200, the operator should first adjust the focus of the evepieces to the operator's refractive error and adjusts the evepieces to the operator's pupillary distance. The operator instructs the patient to place his or her chin on the chinrest, to rest his or her forehead on the forehead rest, and to hold the grips. The operator aligns the level of the patient's eye with the eye level marker, fasten the patient's head with the head belt, and instructs the patient to look at the fixation lamp to stabilize his or her visual axis. The operator looks through the microscope to observe the treatment site. The operator sets laser emission conditions such as laser power output through the control box of the YC-200, turns on the aiming beam, and set the YC-200 to the READY mode. Alignment is achieved when the operator adjusts the joystick and contact lens to align the aiming beam focus with the target position. Finally, the operator presses the hand switch or depresses the optional foot switch to emit the treatment beam in the READY mode while observing the operative field with the slit lamp. One of the reasons for this 510(k) submission is to add the combination delivery unit to connect the subject device to the GYC-500 previously cleared in 510(k) No. K152603. The combination delivery unit allows the operator to perform photocoagulation using the green laser beam (532 nm) or photodisruption using the Nd: YAG laser pulse beam (1064 nm, hereafter referred to as "YAG laser beam") or SLT laser (532 nm, for YC-200 S plus only) while observing the patient's eve with the slit lamp of the YC-200. The delivery unit is connectable to the previously cleared Green Laser Photocoagulator GYC-500, and the subject YC-200. The photocoagulation unit of the combination delivery unit is mounted on the subiect YC-200's slit lamp and is connected to the GYC-500 main body using a connecting cable and a fiber-optic cable. The operator selects the laser beam to be emitted by switching the optical path using the laser beam selector of the combination delivery unit. The optical path of the combination delivery unit for the green laser beam is completely independent from that of the subject YC-200 for the Nd: YAG laser beam. When "YC" is selected by the laser beam selector to select the laser beam to be emitted, the laser refractive mirror is stored in the photocoagulation unit of the delivery unit. When "COAG" is selected by the laser beam selector, the laser refractive mirror comes out from the photocoagulation unit. When the combination delivery unit is attached to the YC-200 and connected to the previously cleared GYC-500 (510(k) No. K152603), the YC-200 works strictly as a diagnostic slit lamp - all photodisruptor and SLT laser functions are disabled. The combination delivery unit is comprised of the photocoagulation unit, and protective filter. The photocoagulation unit adjusts the spot size of the treatment beam and aiming beam emitted from the GYC-500, while the protective filter protects the operator's eve from the reflected green laser beam that can be emitted only when the protective filter is inserted in the optical path. The green laser beam from the GYC-500 requires a delivery unit to be delivered to the patient's eye. The green laser beam is delivered to the patient's eve via the combination delivery unit when it is mounted on the YC-200. The combination delivery unit is intended to save the area occupied by the slit lamp of delivery unit for the GYC-500 by using the slit lamp of the YC-200 consistently during both photocoagulation and photodisruption. Another reason for this 510(k) submission is to add "posterior membranectomy" is to expand treatment options. With the addition of "posterior membranectomy" to the indications for use, the split mirror illumination tower for posterior membranectomy is added as an optional accessory. The split mirror illumination tower was designed to irradiate the target with slit illumination so that the slit illumination is made incident from the center while allowing the YAG treatment beam to pass between the upper and lower mirrors. The previously cleared illumination tower equipped with a tilting function for SLT mode, and illumination tower with the base fixed for YAG mode do not allow the treatment beam to be delivered to the posterior segment of the eye while the operator observes the posterior segment because these illumination towers themselves interrupt the YAG treatment beam. Thus, the previously cleared ones are inappropriate for posterior membranectomy.

The OPHTHALMIC YAG LASER SYSTEM YC-200 consists of a slit lamp and the YAG Laser and is indicated for the performance of posterior capsulotomy, pupillary membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.

The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed laser system using a 1,064 nm Q-switched pulsed Nd: YAG laser as the treatment beam source. The system consists of the types, differing only in the available types of laser emission. The two types are collectively referred to as "YC-200" throughout this 510(k). The operation mode available differs depending on the type. | Type | Model | Emitted Laser (wavelength) | Operation Mode available | |------------------|--------|------------------------------------------------|--------------------------| | YC-200 | YC-200 | Nd: YAG laser (1,064 nm) | YAG mode | | YC-200 S<br>Plus | YC-200 | Nd: YAG laser (1,064 nm)<br>SLT laser (532 nm) | YAG mode<br>SLT mode | As shown in the above table, the YC-200 S Plus provides the operator with two treatment modes, YAG mode and SLT mode, whereas the YC-200 type provides the operator with a single treatment mode, YAG mode. Hereafter, these two types are collectively referred to as "YC-200". In YAG mode, treatment using the YAG treatment beam whose wavelength is 1,064 nm is available. This mode is used mainly for posterior capsulotomy and iridotomy. The 360-degree rotating two-aiming-beam system that separates the YAG aiming beam into two beams is used. The focus position is determined according to the alignment of the beams. In YAG mode, single irradiation mode and burst mode are available. In single mode, one shot of the treatment beam is emitted each time the trigger switch is pressed, whereas in burst mode, two or three shots of the treatment beam are emitted each time the trigger switch is pressed. In YAG mode, the focus shift function to shift the focal points of the YAG treatment beam on the basis of the YAG aiming beam is available. This function allows the operator to shift the focal point of the YAG beam to the posterior chamber side compared to the aiming beam in order to prevent pitting of the intraocular lens. In SLT mode, treatment using the YAG treatment beam whose wavelength is 532 nm is available. This mode is used for selective laser trabeculoplasty. In this mode, a parfocal optical system is used. In the parfocal optical system, the image of an object surface is formed on the target surface. The SLT aiming beam is emitted from the fiber tip (the object surface) so that it appears as a sharply-edged spot on the target surface. The focus position is determined according to the projection status of the beams. In SLT mode, SLT-NAVI that assists the operator in surgery by specifying the laser emission positions and sequence before the treatment is available. The progress status of laser treatment is intuitively displayed in real time in the SLT-NAVI area of the main screen based on the premise that the treatment is proceeding as scheduled. The system is mainly comprised of the YC-200 main body that incorporates a laser source, and a slit lamp that is similar to the previously cleared SL-2000 (K163564), head rest, the control box that controls laser emission, and a connector box. To use the YC-200, the operator should first adjust the focus of the eyepieces to the opera-tor's refractive error and adjusts the eyepieces to the operator's pupillary distance. The operator instructs the patient to place his or her chinrest, to rest his or her forehead on the forehead rest, and to hold the grips. The operator aligns the level of the patient's eye with the eye level marker, fasten the patient's head with the head belt, and instructs the patient to look at the fixation lamp to stabilize his or her visual axis. The operator looks through the microscope to observe the treatment site. The operator sets laser emission conditions such as laser power output through the control box of the YC-200, turns on the aiming beam, and set the YC-200 to the READY mode. Alignment is achieved when the operator adjusts the joystick and contact lens to align the aiming beam focus with the target position. Finally, the operator presses the hand switch or depresses optional foot switch to emit the treatment beam in the READY mode while observing the operative field with the slit lamp.

The NIDEK Specular Microscope CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The NIDEK Specular Microscope CEM-530 which is the subject of this 510(k) is a modification to the NIDEK Specular Microscope CEM-530 cleared in K151706. The only change to the cleared device is to the software which has been revised to improve the accuracy of the automated analysis method. All other aspects of the cleared device remain unchanged. The NIDEK Specular Microscope CEM-530 provides non-contact. high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the corneal endothelial cell density(CD), the coefficient of variation of corneal endothelial cell area (CV), % hexagonality of cells (%HEX), is analyzed through the captured images. The captured images and analysis results of the endothelium are used to assist in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the Center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the the built-in thermal printer or captured images can be transferred to a filing system via LAN connection.

The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to work in conjunction with the following delivery units in ophthalmic photocoagulation procedures: NIDEK SL-1800, SL-1600, ZEISS SL 130, HAAG BQ900, HEINE OMEGA 500

The Yellow Laser Photocoagulator System YLC-500 (hereafter referred to as "YLC-500") is a laser photocoagulator for ophthalmology using the 577 nm optically-pumped semiconductor laser (yellow laser beam) as the treatment beam and 635 nm diode laser (red laser beam) as the aiming beam. Like other conventional laser photocoagulation systems, the YLC-500 can be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YLC-500 is a modified version of the GYC-500 as the primary predicate device and MC-500 Vixi which were the subjects of premarket notification numbers K152603 and K111493. The YLC-500 is mainly comprised of the main body that incorporates a laser source, the control box that controls laser emission, and a delivery unit that guides the laser beam emitted from the main body to the patient's eye. To use the YLC-500, the operator sets laser emission conditions such as laser power output, spot size, and exposure time according to the condition of treatment site through the control box of the YLC-500 or operation part of the connected delivery unit. When using an (attachable) slit lamp delivery unit, the operator observes the treatment site with the slit lamp, and aligns the treatment beam and aiming beam to the site. Then the operator presses the foot switch to emit the treatment beam and aiming beam to the treatment site from the exit end of the YLC-500 system in a READY status while observing the operative field with the slit lamp. As the treatment beam is optically coaxial to the aiming beam, alignment is achieved when the operator aligns the aiming beam to the treatment site. When the foot switch is pressed under the condition, the treatment beam of the set spot size is irradiated at which the aiming beam is projected. The operator can also select the laser irradiation pattern from a single laser spot and multiple laser spots in a scanning manner when a scan (attachable) delivery unit is connected to the YLC-500. Various types of the delivery units are available for the YLC-500. As the delivery units using a slit lamp, broadly speaking, two types of delivery units are available. One is called "Slit lamp delivery unit" integrating a slit lamp and a laser delivery unit. The other is called "Attachable delivery unit" that is the laser delivery unit integrative filer and so on for connection to the slit lamp owned by the user. Furthermore, the slit lamp delivery units are classified into "Slit lamp delivery unit" that delivers a single laser spot only, and "Scan slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. In a similar manner, the attachable delivery units are further classified into "Attachable slit lamp delivery unit" that delivers a single laser spot only, and "Scan attachable slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. The YLC-500 connected with a scan (attachable) delivery unit is called "Yellow Scan Laser Photocoagulator YLC-500 Vixi". Various slit lamp delivery units are available that allow for the adaptation of the YLC-500 to a slit lamp. An optical fiber cable is connected from the YLC-500 main body to the slit lamp, thereby allowing the laser beam to be sent to the delivery unit. With the delivery unit, the patient can be treated in a seated position. The following slit lamp delivery units are available: Slit lamp delivery unit (NIDEK SL-1800 type), Scan slit lamp delivery unit (NIDEK SL-1800 type), Attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type), and Scan attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, HAAG BQ900). Other than the (scan and/or attachable) slit lamp delivery units, a binocular indirect ophthalmoscope (B.I.O.) delivery unit is available. The B.I.O. delivery unit enables photocoagulation using a vellow laser beam (577 mm) while observing the patient's eye with a binocular indirect ophthalmoscope. With the delivery unit, the patient can be treated in a supine position. The delivery unit (Heine Omega 500 type) connects to the YLC-500 main body via an optical fiber cable. The delivery unit consists of a binocular indirect ophthalmoscope (with headband), a 20 D condensing lens, illumination lamp, and stand. The headband fits over the operator's head and has height and circumference adjustment knobs. A working distance control sets the distance among the operator, the patient, and 20 D condensing lens, which can be varied within a range of 300 to 700 mm. The treatment and aiming beam spot size can also be selected by changing working distance (with the 20D condensing lens). The delivery units allow transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. The operator chooses the optimal delivery unit for the purpose of photocoagulation of the patient's eye.

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.

Color retinography Fixation examiner Fundus-related microperimetry

The Microperimeter MP-3performs the following basic functions: Color retinography Fixation examiner Fundus-related microperimetry

The Green Laser Photocoagulator GYC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Green Laser Photocoagulator GYC-500 ("GYC-500") is a laser photocoagulator for ophthalmology using the 532 nm diode-pumped solid-state laser (green laser beam) as the treatment beam and 635 nm diode laser (red laser beam) as the aiming beam. Like other conventional laser photocoagulation system, the GYC-500 can be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The GYC-500 is a modified version of the GYC-1000 which was the subject of premarket notification number K 032085. The GYC-500 is mainly comprised of the main body that incorporates a laser source, the control box that controls laser emission, and a delivery unit that guides the laser beam emitted from the main body to the patient's eye. To use the GYC-500, the operator sets laser irradiation conditions such as laser output and laser application time according to the condition of treatment site through the control box of the GYC-500 or operation part of the connected delivery unit. When using a (attachable) slit lamp delivery unit, the operator observes the treatment site with the slit lamp, and aligns the treatment beam and aiming beam to the site. Then the operator presses the foot switch to emit the treatment beam and aiming beam to the treatment site from the exit end of the GYC-500 system in a READY status while observing the operative field with the slit lamp. As the treatment beam is optically coaxial to the aiming beam, alignment is achieved when the user aligns the aiming beam to the treatment site. When the foot switch is pressed under the condition, the treatment beam of the set spot size is irradiated at which the aiming beam is projected. The operator can also select the laser irradiation pattern from a single laser spot and multiple laser spots in a predetermined pattern in a scanning manner. Various types of the delivery units are available for the GYC-500. As the delivery units using a slit lamp, broadly speaking, two types of delivery units are available. One is called "Slit lamp delivery unit" integrating a slit lamp and a laser delivery unit. The other is called "Attachable delivery unit" that is the laser delivery unit integrating a protective filer and so on for connection to the slit lamp owned by the user. Either the slit lamp delivery units or attachable delivery units are divided into three types: 1) the unit only with the fixed protective filter that remains inserted into the optical path and without the micromanipulator (used for fine adjustment of the laser beam position), 2 ) the unit with the fixed protective filter or electrically-powered one (either filter is factory configured) and with the micromanipulator, and 3) the unit only with the electrically-powered protective filter, with the micromanipulator, and with the spot size control which is different from the aforementioned two types in mechanical structure. Furthermore, the slit lamp delivery units are classified into "Slit lamp delivery unit" that delivers a single laser spot only, and "Scan slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. In a similar manner, the attachable delivery units are further classified into "Attachable slit lamp delivery unit" that delivers a single laser spot only, and "Scan attachable slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. The GYC-500 connected with a scan (attachable) delivery unit is called "Green Scan Laser Photocoagulator GYC-500 Vixi". Various slit lamp delivery units are available that allow for the adaptation of the GYC-500 to a slit lamp. A fiber optic cable is connected from the GYC-500 main body to the slit lamp, thereby allowing the laser beam to be sent to the delivery unit. With the delivery unit, the patient can be treated in a seated position. The following slit lamp types are available: Slit lamp delivery unit (NIDEK SL-1800 type), Scan slit lamp delivery unit (NIDEK SL-1800 type), Attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, ZEISS 30 SL/M type, HAAG 900BM/900BQ type), and Scan attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, ZEISS 30 SL/M type, HAAG 900 BQ type). Other than the (scan and/or attachable) slit lamp delivery units, a binocular indirect ophthalmoscope (B.I.O.) delivery unit and a combination delivery unit are available. The B.I.O. delivery unit allows the operator to perform photocoagulation while observing the fundus with a binocular indirect ophthalmoscope. With the delivery unit, the patient can be treated in a supine position. The B.I.O. delivery unit (Heine Omega 500 type and Keeler All Pupil II type) connects to the GYC-500 main body via a fiber optic cable. The B.I.O. delivery unit consists of a binocular indirect ophthalmoscope (with headband), a 20 D condensing lens illumination lamp, and stand. The headband fits over the operator's head and has height and circumference adjustment knobs. A working distance control sets the working distance, which can be varied within a range of 300 to 700 mm. The treatment and aiming laser spot size can also be selected by changing working distance (with the 20D condensing lens). The combination delivery unit is mounted on the NIDEK Ophthalmic YAG Laser System YC-1800's slit lamp and is connected to the GYC-500 main body using a connecting cable and a fiber-optic cable. The delivery unit allows the operator to perform photocoagulation using the green laser beam (532 nm) or photodisruption using an Nd: YAG laser beam while performing observation of the eye with the slit lamp of the YC-1800. The optical path for the green laser beam is completely independent from that for the Nd: YAG laser pulse beam. The operator selects the laser beam to be emitted by switching the optical path using the laser beam selector of the delivery unit. This delivery unit is intended to save the area occupied by the slit lamp for the GYC-500 and that for the YC-1800 by using the slit lamp of the YC-1800 consistently for both photocoagulation and photodisruption. The delivery units allow transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. The operator chooses the optimal delivery unit for the purpose of photocoagulation of the patient's eye.

The Specular Microscope CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The Nidek Specular Microscope CEM-530 provides non-contact, high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of the endothelium are used in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the built-in thermal printer or captured images can be transferred to a filing system via LAN connection. The Specular Microscope CEM-530 cleared in this 510(k) is identical to the Specular Microscope CEM-530 cleared in K130565 with the addition of a new analysis mode: Center Point Method. All other aspects of the cleared device remain unchanged.

The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as: - axial length; - corneal thickness; - anterior chamber depth; - corneal curvature radii; - corneal cylinder axis; - white-to-white distance; and - pupil diameter. Axial length and corneal thickness can also be measured using ultrasound. The OPTICAL BIOMETER AL-Scan also performs calculations to assist physicians in determining the power of the intraocular lens for implantation. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (A-mode)

The OPTICAL BIOMETER AL-Scan ("AL-Scan") measures ocular measurements including: axial length, corneal thickness, anterior chamber depth, corneal curvature radii, corneal cylinder axis, white-to-white distance, and pupil diameter. It measures these necessary values successively through a non-contact optical measurement method. The AL-Scan measures as a single unit the values necessary to calculate the power of an IOL for cataract surgery. Two optional ultrasonic probes (A-scan Probe and Pachymetry Probe) are available for use in the event the optical measurement is unsuccessful. The A-scan probe scans the axial length, anterior chamber depth, lens thickness and the pachymetry probe scans the corneal thickness. Both probes utilize an ultrasonic measurement function by touching the probe to the cornea. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.