Search Filters

Search Results

Found 103 results

510(k) Data Aggregation

    K Number
    K222933
    Device Name
    MYAH
    Manufacturer
    VISIA Imaging S.r.l.
    Date Cleared
    2023-06-29

    (276 days)

    Product Code
    MXK, HKI
    Regulation Number
    886.1850
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    Not Found
    Ask a Question
    K Number
    K222372
    Device Name
    Kowa SL-19
    Manufacturer
    Kowa Company, Ltd.
    Date Cleared
    2022-11-21

    (108 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
    Ask a Question
    K Number
    K211868
    Device Name
    MYAH
    Manufacturer
    VISIA imaging S.R.L.
    Date Cleared
    2022-03-01

    (258 days)

    Product Code
    MXK
    Regulation Number
    886.1850
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    Not Found
    Ask a Question
    K Number
    K202989
    Device Name
    Myopia Master
    Manufacturer
    OCULUS Optikgeräte GmbH
    Date Cleared
    2021-07-14

    (287 days)

    Product Code
    MXK, HJO
    Regulation Number
    886.1850
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
    Ask a Question
    K Number
    K203244
    Device Name
    CellChek 20 rc
    Manufacturer
    Konan Medical, Inc.
    Date Cleared
    2021-06-15

    (224 days)

    Product Code
    NFJ, NQE
    Regulation Number
    892.2050
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CellChek 20 rc is a software program intended to analyze ophthalmic images captured by the Konan Specular Microscope XVII for examination of corneal endothelium.
    Device Description
    Konan Medical has developed the CellChek 20 rc to provide photographic data taken exclusively by the Konan Specular Microscope XVII, CellChek 20, which was cleared by FDA under 510(k) number K191558 on Mar 26, 2020, to research and learning centers for the advancement of ophthalmic sciences and practice. The CellChek 20 rc was developed based on the software program of CellChek 20. CellChek 20 rc is a software program to analyze ophthalmic images for examination of corneal endothelium. This has the cell counting analysis program, and allows for analysis of the images of the cell distribution of the eye. The software program is installed on a general-use computer to analyze corneal endothelial images photographed exclusively by the Konan Specular Microscope XVII, CellChek 20. The analysis function is to calculate mainly the cell density, the coefficient of variation of cell area, and the percent hexagonality. In the manual methods, cornea endothelial cells and cell boundaries are actually identified by users. In the automatic methods, this software detects cells and cell boundaries, however, users can modify the detection results. During operating, the users interact with the software by visually placing dots in the center of each of cells and/or by tracing cell boundaries displayed on a computer screen, or use the automatic algorithm.
    Ask a Question
    K Number
    K201724
    Device Name
    Pentacam AXL Wave
    Manufacturer
    OCULUS Optikgerate GmbH
    Date Cleared
    2020-10-21

    (120 days)

    Product Code
    MXK, HJO
    Regulation Number
    886.1850
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
    Ask a Question
    K Number
    K191558
    Device Name
    Konan Specular Microscope XVII
    Manufacturer
    Konan Medical, Inc.
    Date Cleared
    2020-03-26

    (288 days)

    Product Code
    NQE
    Regulation Number
    886.1850
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konan Specular Microscope XVII, CellChek 20, 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.
    Device Description
    The Konan Specular Microscope XVII, CellChek 20, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis program are included, and allow for analysis of the images of the cell distribution of the eye. When photographing the corneal endothelium, the device performs the alignment and automatically focuses by capturing the reflected light from patient's eye with the camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, as well as computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory and can be preserved by using a printer. The parts of the device that come into contact with a patient are the forehead rest and the chin rest. Their material is acrylonitrile butadiene styrene (ABS), the same material used in reference device and one with proven biocompatibility. The function of the software installed in the device is to calculate mainly the cell density, the coefficient of variation of cell area and the percent hexagonality. In the manual methods, Actual identification if the cells and cell boundaries is done by the (physician) user. In the automatic method, the software detects the cells and cell boundaries, however, the user is given the opportunity to make corrections. In use, the user interacts with the software by visually placing dots in the center of cells as or by tracing cell boundaries as they appear or on a screen or uses the automatic algorithm.
    Ask a Question
    K Number
    K193188
    Device Name
    MiiS Horus Eye Anterior Camera
    Manufacturer
    Medimaging Integrated Solution Inc. (MiiS)
    Date Cleared
    2020-01-14

    (57 days)

    Product Code
    HJO, HKI
    Regulation Number
    886.1850
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
    Ask a Question
    K Number
    K192045
    Device Name
    Ophthalmic Yag Laser System YC-200
    Manufacturer
    Nidek Co., Ltd.
    Date Cleared
    2019-11-15

    (107 days)

    Product Code
    HQF, HJO
    Regulation Number
    886.4390
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
    Ask a Question
    K Number
    K182659
    Device Name
    Galilei G6 Lens Professional
    Manufacturer
    SIS AG, Surgical Instrument Systems
    Date Cleared
    2019-07-25

    (303 days)

    Product Code
    MXK, HJO
    Regulation Number
    886.1850
    Why did this record match?
    Search-Everything :

    Matched: '886.1850'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
    Ask a Question

    Page 1 of 11