| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04059237000877 | 88036 | OBO | Tomography, Optical Coherence | 2 | ANTERION | ||
| 2 | 04059237000617 | 88036 | OBO | Tomography, Optical Coherence | 2 | ANTERION | ||
| 3 | 04059237000754 | Software with HEYEX 2 V1.2.3 | OBO | Tomography, Optical Coherence | 2 | ANTERION | ||
| 4 | 04059237000242 | HEYEX 2 SW V2.2 | HPT,MYC,OBO,MXK | Perimeter, Automatic, Ac-Powered,Ophthalmoscope,Laser,Scanning,Tomography, Optic Perimeter, Automatic, Ac-Powered,Ophthalmoscope,Laser,Scanning,Tomography, Optical Coherence,Device,Analysis,Anterior Segment | 1 | SPECTRALIS, HRT3, HEP | ||
| 5 | 04059237000747 | N/A | 18829 | MXK | Device, Analysis, Anterior Segment | TOMOCAP | ||
| 6 | 04059237000372 | HEP with HEYEX 2 SW V3.2c | HOO | Perimeter, Ac-Powered | 1 | HEP | ||
| 7 | 04059237000396 | Image Capture Module SW V1.2.4 | HOO,OBO,MYC | Perimeter, Ac-Powered,Tomography, Optical Coherence,Ophthalmoscope, Laser, Scanning | 1 | SPECTRALIS, HEP | ||
| 8 | 04059237000112 | VAO | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 9 | 04059237000570 | Software 6.12_US | MYC,OBO | Ophthalmoscope, Laser, Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 10 | 04059237000051 | SP-PWS-2000A | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 11 | 04059237000044 | SP-PWS-1000A | MYC,OBO | Ophthalmoscope,Laser,Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 12 | 04059237000150 | UWF1 | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 13 | 04059237000716 | SP-PWS-2001A [>20000] | MYC,OBO | Ophthalmoscope, Laser, Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 14 | 04059237000594 | Software with HEYEX 2 V6.12_US | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope, Laser, Scanning | 2 | SPECTRALIS | ||
| 15 | 04059237000501 | SP-PWS-1001A | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 16 | 04059237000136 | WFO2 | MYC,OBO | Ophthalmoscope,Laser,Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 17 | 04059237000839 | Software with HEYEX 2 V7.0-US | MYC,OBO | Ophthalmoscope, Laser, Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 18 | 04059237000815 | Software V7.0-US | MYC,OBO | Ophthalmoscope, Laser, Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 19 | 04059237000549 | Software with HEYEX 2 V6.10-US | MYC,OBO | Ophthalmoscope, Laser, Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 20 | 04059237000525 | Software V6.10-US | MYC,OBO | Ophthalmoscope, Laser, Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 21 | 04059237000488 | Software with HEYEX 2 V6.14_US | MYC,OBO | Ophthalmoscope, Laser, Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 22 | 04059237000464 | Software 6.13_US | MYC,OBO | Ophthalmoscope, Laser, Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 23 | 04059237000358 | Product Famliy with HEYEX 2 SW V6.9b-US | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope, Laser, Scanning | 2 | SPECTRALIS | ||
| 24 | 04059237000341 | Product Family SW V6.9.1-US | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope, Laser, Scanning | 2 | SPECTRALIS | ||
| 25 | 04059237000334 | Rostock Cornea Module SW V1.5a | MXK | Device,Analysis,Anterior Segment | 2 | HRT3 | ||
| 26 | 04059237000310 | Product Family SW V6.8a-US | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 27 | 04059237000303 | Product Family SW V6.8-US | MYC,OBO | Ophthalmoscope,Laser,Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 28 | 04059237000297 | SPEC-CAM-S2610 | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 29 | 04059237000280 | SPEC-CAM-S2600 | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 30 | 04059237000273 | Rostock Cornea Module SW V1.5 | MXK | Device,Analysis,Anterior Segment | 2 | HRT3 | ||
| 31 | 04059237000259 | Image Capture Module SW V1.2 | MYC,OBO | Ophthalmoscope,Laser,Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 32 | 04059237000211 | HMO | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 33 | 04059237000105 | Product Family SW V6.6 | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 34 | 04059237000099 | SPEC-CAM-S3610 | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 35 | 04059237000082 | SPEC-CAM-S1610 | MYC,OBO | Ophthalmoscope,Laser,Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 36 | 04059237000075 | SPEC-TSP | MYC,OBO | Ophthalmoscope,Laser,Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 37 | 04059237000068 | SP-PWS-2001A | MYC,OBO | Ophthalmoscope,Laser,Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 38 | 04059237000037 | SPEC-CAM-S3600 | MYC,OBO | Ophthalmoscope,Laser,Scanning,Tomography, Optical Coherence | 2 | SPECTRALIS | ||
| 39 | 04059237000020 | SPEC-CAM-S2000 | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS | ||
| 40 | 04059237000013 | SPEC-CAM-S1600 | OBO,MYC | Tomography, Optical Coherence,Ophthalmoscope,Laser,Scanning | 2 | SPECTRALIS |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08034028770463 | MYOPIA EXPERT 700 | BMT00004 | BIOMETER - TOPOGRAPHER | MYOPIA EXPERT 700 | VISIA IMAGING SRL |
| 2 | 08034028770456 | MYAH | 42-0000983US | MYAH | VISIA IMAGING SRL | |
| 3 | 07640167751242 | G6 | 410.030.007 | Galilei G6 Lens Professional | GALILEI | SIS AG, SURGICAL INSTRUMENT SYSTEMS |
| 4 | 07640167751235 | G4 | 410.030.004 | Galilei Dual Scheimpflug Analyzer | GALILEI | SIS AG, SURGICAL INSTRUMENT SYSTEMS |
| 5 | 04573344510024 | ARGOS ver1.5 | ARGOS is a non-invasive, non-contact biometer based on swept-source optical cohe ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherencetomography (SS-OCT). The device is intended to acquire ocular measurements as well asperform calculations to determine the appropriate intraocular lens (IOL) power and typefor implantation during intraocular lens placement. ARGOS measures the following 9parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness,K-values (Radii of flattest and steepest meridians), Astigmatism, White-to-white(corneal diameter) and Pupil Size. The Reference Image functionality is intended for useas a preoperative and postoperative image capture tool.It is intended for use by ophthalmologists, physicians, and other eye-care professionalsand may only be used under the supervision of a physician. | OPTICAL BIOMETER | SANTEC CORPORATION | |
| 6 | 04573344510017 | ARGOS | ARGOS is a non-invasive, non-contact biometer based on swept-source optical cohe ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, Whiteto- white (corneal diameter) and Pupil Size. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician. | OPTICAL BIOMETER | SANTEC CORPORATION | |
| 7 | 04059237000747 | N/A | 18829 | TOMOCAP | HEIDELBERG ENGINEERING GMBH | |
| 8 | 04059237000334 | Rostock Cornea Module SW V1.5a | HRT3 | HEIDELBERG ENGINEERING GMBH | ||
| 9 | 04059237000273 | Rostock Cornea Module SW V1.5 | HRT3 | HEIDELBERG ENGINEERING GMBH | ||
| 10 | 04059237000266 | HRT3 RCM | HRT3 | HEIDELBERG ENGINEERING GMBH | ||
| 11 | 04059237000242 | HEYEX 2 SW V2.2 | SPECTRALIS, HRT3, HEP | HEIDELBERG ENGINEERING GMBH | ||
| 12 | 04049584029959 | 68130 | The Myopia Master combines different measuring functions in one unit.The Auto-Re The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry. | Myopia Master | OCULUS OPTIKGERÄTE GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG | |
| 13 | 04049584029942 | 68120 | The Myopia Master combines different measuring functions in one unit.The Auto-Re The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry. | Myopia Master | OCULUS OPTIKGERÄTE GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG | |
| 14 | 04049584025357 | 70020 | While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes to evaluate several parameters of the cornea, pupil, anterior chamber and lens. The axial length of the eye is measured and displayed by interferometry. Wavefront measurement uses a Hartmann Shack aberrometer to detect the low and high order aberrations of the entire eye. | Pentacam AXL Wave | OCULUS OPTIKGERÄTE GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG | |
| 15 | 04049584012333 | 70100 | While rotating around the eye, the Pentacam® AXL captures Scheimpflugimages of t While rotating around the eye, the Pentacam® AXL captures Scheimpflugimages of the anterior eye segment through varying axes. TheScheimpflug images created during an examination are transmitted tothe connected PC.The axial length of the eye is measured and displayed by interferometry. | Pentacam AXL | OCULUS OPTIKGERÄTE GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG | |
| 16 | 04049584000217 | 65000 | The PARK 1 combines three measuring functions in one unit.Auto-RefractometerAn i The PARK 1 combines three measuring functions in one unit.Auto-RefractometerAn infrared light source projects measuring light onto the retina of the eyefrom where it is reflected back to the shutter location. Sensitive sensorchips, or CCD cameras now register the deviation of the reflected light fromthe shutter location. The deviation depends on the ametropia. From that, anintegrated microcomputer calculates the ametropia in D, based on thesphere, cylinder and cylinder axis position.1 Measuring ocular / Patient eyepiece 4 Chin rest2 Keratometer ring 5 Marking for the eye height3 Pachycam camera glass coverKeratometerTo determine the curvature of the cornea, a reflected image of the corneais captured by a camera sensor and is measured.The reflection of test marks and of a ring is used as the reflected image.This allows the central radii of the cornea to be determined.PachymeterThe pachymetry principle uses Scheimpflug images of the cornea, whichare analysed by a built-in computer.600 Absolute data points are evaluated with the Scheimpflug image. Themeasuring range lies on a 4 mm slit through the apex.The slit light illuminates a sectional plane from the front surface of the corneato the back surface. The transparent cells of the cornea scatter the slitlight such that the sectional plane appears as if it were self-luminous.This is captured at an angle of 45° through the pupil by a camera, wherebythe image plane of the camera is also tilted 45° to the optical axis of thecamera lens, in order to sharply focus the light-scattering cornea planeonto the image plane of the camera (Scheimpflug image).Thanks to this arrangement, sharp sectional images of the cornea can be attained. | Park 1 | OCULUS OPTIKGERÄTE GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG | |
| 17 | 04049584000026 | 70900 | The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to takephotographs of the anterior segment of the eye, table mounted and AC powered. The systemis based on the Scheimpflug Principle for Slit Image photography. The device consists of ameasurement unit, power supply and a CPU. The measuring system uses blue light (UV-free)given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuringsystem offers the possibility of automatically rotation to get photographs of every part of theeye. The system calculates from the photos a 3D-model1 of the eye | Pentacam HR | OCULUS OPTIKGERÄTE GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG | |
| 18 | 04049584000019 | 70700 | The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to takephotographs of the anterior segment of the eye, table mounted and AC powered. The systemis based on the Scheimpflug Principle for Slit Image photography. The device consists of ameasurement unit, power supply and a CPU. The measuring system uses blue light (UV-free)given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuringsystem offers the possibility of automatically rotation to get photographs of every part of theeye. The system calculates from the photos a 3D-model1 of the eye. | Pentacam | OCULUS OPTIKGERÄTE GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG | |
| 19 | 03664188002200 | VX220 | The VX220 is a multifunctional eye diagnostic device. There are several operatio The VX220 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: keratometer, corneal topographer, tonometer,and pachymeter and retro illumination | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | |
| 20 | 03664188001203 | VX120 | The VX120 is a multifunctional eye diagnostic device. There are several operatio The VX120 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, tonometer, pachymeter and retro illumination. | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | |
| 21 | 03664188000909 | VX130 | The VX130 is a multi-function diagnostic device combining wavefront aberometer, The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the centralcornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil ImageImage of the cornea relative to the iris | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | |
| 22 | 03664188000046 | VX120+ | The VX120+ is a multi-function diagnostic device combining corneal topographer, The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation. Photographing the eye and taking images of the eye to evaluate the thickness of the cornea.Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT)Meibomian glands imagingEvaluation of tear meniscus height | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | |
| 23 | 03664188000039 | VX130+ | The VX130+ is a multifunctional eye diagnostic device. There are several operati The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefractometer, keratometer, corneal topographer, tonometer, multi-slit pachymeter, tear-film analyzer , and retro illumination.The VX130+ is a multi-function diagnostic device combining wavefront aberometer, cornealtopographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil ImageImage of the cornea relative to the irisAnalysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT)Meibomian glands imagingEvaluation of tear meniscus height | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS |