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510(k) Data Aggregation

    K Number
    K223739
    Device Name
    VS Tabletop Tonometer
    Manufacturer
    Medimaging Integrated Solution Inc
    Date Cleared
    2023-11-08

    (329 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VS Tabletop Tonometer is a digital tonometer intended to measure intraocular pressure of the human eye.
    Device Description
    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.
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    K Number
    K190382
    Device Name
    Intraocular Pressure Tonometer EASYTON
    Manufacturer
    Company Elamed
    Date Cleared
    2019-12-06

    (290 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tonometer Easyton is indicated for the measurement of intraocular pressure in human eyes.
    Device Description
    The principle of EASYTON measurement is based on simultaneous use of the two types of measuring actions – static and dynamic. Both actions are carried out by the vibrator's rod on the eyelid. Static action is carried out during the time of measurement and determined by the weight of the vibrator. Dynamic exposure represents itself during the vibrating action with frequency: about 150 HZ and amplitude: the millimeter hundredth parts and tactile is felt as soft vibration. Vibrator's rod is elastically movable in its axial direction and is set in oscillatory motion by electromagnetic way. While carrying out the measurement, the rod is put up on the eyelid, sagging (pressing the eyelid down with its weight about 10g and is fixed on sclera or an eye cornea forming elastic system of eye-vibrator with total mechanical rigidity. This system is disturbed from the equilibrium state by the rod's short term electromagnetic removal. In a system within tan equilibrium state restoration there are arising free damped vibration. Functional connection between elastic system rigidity and the period of is own vibration is known. This period is measured by the tonometer and is used for IOP calculation being shown on the display.
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    K Number
    K181260
    Device Name
    MiiS Horus Scope DPT 100
    Manufacturer
    Medimaging Integrated Solution Inc. (MiiS)
    Date Cleared
    2019-06-21

    (406 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of eyeball.
    Device Description
    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.
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    K Number
    K181143
    Device Name
    Keeler TonoCare Tonometer
    Manufacturer
    Keeler Instruments Inc.
    Date Cleared
    2019-02-08

    (283 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keeler TonoCare Tonometer is a hand-held, battery operated, non-contact tonometer intended to be used for measuring intraocular pressure (IOP) of the human eye with less than 3D in corneal astigmatism.
    Device Description
    The Keeler TonoCare Tonometer is designed to measure Intra Ocular Pressure (IOP) to aid in the screening and diagnosis of glaucoma without contacting the eye. The Keeler TonoCare Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K093298. Both products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement. The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built-in light source increases until the predefined firing thresholds on the built-in photodiodes have been met. Once this condition has been met, a quantized puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on-board microprocessor.
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    K Number
    K180820
    Device Name
    Tono Vue Non-Contact Tonometer
    Manufacturer
    Crystalvue Medical Corporation
    Date Cleared
    2018-12-14

    (260 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TonoVue is a non-contact tonometer that is intended to measure the intraocular pressure of the human eye in vivo. The TonoVue is a non-contact tonometer that intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism.
    Device Description
    TonoVue Tonometer is designed to non-contact tonometer (NCT) that measures the intraocular pressure (IOP) by delivering a soft air puff without contacting eyes directly. It's designed as a full auto-alignment and All-In-One desktop type medical device with built-in thermal line printer. The dimensions of whole device are about 500mm (H) x 260mm (W) x 500mm (L). The AC power input port and a USB port are set at the bottom side of the device, but the USB port only for engineering use. Based on the Imbert-Fick principle, the IOP is calculated by dividing the amount of air pressure into the area of applanated surface. TonoVue utilizes a rapid air puff to apply force for flattening the cornea of human eye, and an advanced electro-optical system to monitor its deformation. The puff force increases until the cornea is applanated over the predetermined area and detected by the pressure sensor inside TonoVue, and the IOP can be calculated.
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    K Number
    K162067
    Device Name
    VX130 Ophthalmic Diagnostic Device
    Manufacturer
    LUNEAU SAS
    Date Cleared
    2017-04-24

    (272 days)

    Product Code
    HKX, MXK
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measuring the refraction of the eye giving both lower and higher order aberrations Measurement of 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 corneal thickness map. Scheimpflug imaging. Anterior chamber imaging. Pupil image. Image of the cornea relative to the iris.
    Device Description
    The VX130 is a multifunctional ophthalmic diagnostic device. The VX130 combined wavefront aberrometer, corneal topographer, cataract screening device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units. The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the eye. Retro illumination is used to image ocular opacities. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. A linear scanning Scheimpflug pachymeter measures the thickness of the cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. Anterior and posterior corneal shape are also measured from the Scheimpflug images. An air puff non-contact tonometer is included for measurement of the intraocular pressure. The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.
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    K Number
    K143086
    Device Name
    VX120 Ophthalmic Diagnostic Device
    Manufacturer
    LUNEAU SAS
    Date Cleared
    2015-06-01

    (217 days)

    Product Code
    HKX, HKO, MXK
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VX120 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 comea 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.
    Device Description
    The VX120 is a multifunctional ophthalmic diagnostic device. The VX120 combined wavefront aberrometer, corneal topographer, retro illumination device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units. The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the refraction of the eye. Retro illumination is used to image ocular opacities. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. The Scheimpflug pachymeter measures the thickness of the central cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. An air puff non-contact tonometer is included for measurement of the intraocular pressure. The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.
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    K Number
    K113066
    Device Name
    CORVIS ST
    Manufacturer
    OCULUS OPTIKGERATE GMBH
    Date Cleared
    2012-11-08

    (388 days)

    Product Code
    HKX, MXK
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Corvis ST is intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism. In addition, the Corvis ST is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea.
    Device Description
    The Corvis ST performs the following two functions: Tonometry and Pachymetry. The Corvis ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. The eye is illuminated and during the air puff, a high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera analyzes a sequence of 140 Scheimpflug images of the cornea to determine intra-ocular pressure. The Corvis ST measure corneal thickness and shape based on sectional images when the cornea is not influenced by the air puff. The pachymetry measurements of the Corvis ST and the cleared Oculus predicate use the same image processing routine for analysis to obtain corneal thickness measurements. Tonometry and pachymetry functions can be performed during the same evaluation or separately.
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    K Number
    K111710
    Device Name
    FULL AUTO TONOMETER MODEL TX-20
    Manufacturer
    CANON, INC.-MEDICAL EQUIPMENT GROUP
    Date Cleared
    2011-09-20

    (92 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraocular pressure of the human eye.
    Device Description
    The Canon Full Auto Tonometer TX-20 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure with the help of a full auto-alignment system.
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    K Number
    K093298
    Device Name
    PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
    Manufacturer
    KEELER INSTRUMENTS, INC.
    Date Cleared
    2010-12-10

    (415 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    HKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulsair IntelliPuff Non-Contact Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. The Pulsair Desktop Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
    Device Description
    The Keeler Pulsair Tonometer product family are non-contact tonometers and are used to measure intraocular pressure without contacting the eye to aid with the screening and diagnosis of glaucoma. The product family consists of the Pulsair Intellipuff (Hand Held device) and the Pulsair Desktop which is mounted on a desk. The Pulsair Intellipuff Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K990257 whilst the Pulsair Desktop Tonometer ergonomics have been adapted to suite the Desktop mounted market place. Both products use the same concept of measurement as the predicate device and contain many common components. All of the products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement. The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built in light source increases until the predefined firing thresholds on the built in photodiodes have been met. Once this condition has been met, a quantised puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on board microprocessor.
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