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510(k) Data Aggregation

    K Number
    K241447
    Device Name
    iCare ST500 (TA04)
    Manufacturer
    Icare Finland Oy
    Date Cleared
    2024-09-27

    (128 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iCare ST500 tonometer is a device intended to be used for the intraocular pressure of the human eye. The iCare ST500 tonometer is intended to be used by healthcare professionals.
    Device Description
    The iCare ST500 tonometer is based on a patented, induction-based rebound method, which allows intraocular pressure (IOP) to be measured by a healthcare professional accurately, rapidly and without an anesthetic. The iCare ST500 tonometer measures a patient's IOP while he or she is in an upright (sitting) position. It is attached to a slit lamp with the ST500 Adapter, making it easy to use during a standard eye exam. This tonometer is designed only for use with a slit lamp not as a handheld device. The tonometer is compatible with most of the common slit lamp models on the market. The tonometer system consists of the iCare ST500 tonometer (together with ST500 Remote and ST500 Adapter, ST500 SmartCradle and a medical power supply used with ST500 SmartCradle), and a compatible printer and slit lamp. With the iCare rebound measurement method, a miniature, lightweight, single-use probe is launched in a direction perpendicular to the surface of the center of the cornea of the eye. The probe is composed of a medical grade plastic tip and a metal shaft. The metal shaft is magnetized prior to the measurement. During the measurement, the probe can be considered to act like a moving magnet that induces an electric signal in the surrounding coil allowing for a highly accurate measurement of the probe's motion. After launching. the probe briefly contacts the cornea and bounces back. The tonometer records multiple parameters covering the motion of the probe, including deceleration, and rebound time. Using a proprietary algorithm, the device can calculate the eye's IOP. The displayed IOP reading is derived from the results from a sequence of six individual probe rebounds. The displayed IOP measurement is also stored in the tonometer's memory for later retrieval. The iCare ST500 tonometer has a rechargeable battery and can be charged in the ST500 SmartCradle powered by a medical power supply. The tonometer can be operated by using the buttons on the tonometer or by using the wireless battery-operated ST500 Remote control.
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    K Number
    K233516
    Device Name
    Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
    Manufacturer
    Reichert, Inc.
    Date Cleared
    2024-05-01

    (182 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes is intended to be used for the measurement of intraocular pressure of the human eye.
    Device Description
    The Reichert Tono-Vera® Tonometer is a hand-held, battery powered instrument that utilizes rebound methodology to measure the intraocular pressure (IOP) of the eye. The tonometer propels a small, plastic-tipped measurement probe in a controlled manner against a patient's unanesthetized eye in order to calculate IOP. The device has a simple, four-button control system and an LCD that provides information to the operator and displays measurement results. There are two Tono-Vera Tonometer models: · Tono-Vera Tonometer Starter Kit, AA Battery, Model 16305; and • Tono-Vera Tonometer Starter Kit, Rechargeable, Model 16306. Both models of the Tono-Vera Tonometer have a required accessory, the Ocu-Dot® Tonometer Probe, model 16318. The Ocu-Dot Tonometer Probe is a sterile, single-use, disposable accessory. The Tono-Vera Tonometer utilizes a camera-based alignment system, called ActiView™ to improve alignment with the apex of the cornea and reduce measurement variability caused by operator technique. The measuring process starts automatically once alignment conditions are fulfilled. The device has two measurement options: 3+ (Quick) Measurement Option and 6 Measurement Option. Both the 3+ (Quick) Measurement Option and 6 Measurement Option use the same calculation for the IOP result. The 3+ (Quick) Option can calculate a final IOP result with as few as three measurements. The 6 Measurement Option always uses six measurements to calculate the final IOP result. The Tono-Vera Tonometer can be connected to a computer with ReichertSync® installed on it. Data from ReichertSync can be imported by an EMR system. The Tono-Vera Tonometer determines IOP by detecting and analyzing the motion of the measurement probe as it briefly contacts the cornea.
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    K Number
    K234037
    Device Name
    CATS-L Tonometer™ Prism
    Manufacturer
    CATS Tonometer, LLC
    Date Cleared
    2024-02-09

    (50 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CATS-L® Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.
    Device Description
    The CATS-L Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. The CATS-L prism is made of PMMA, the corneal contact diameter is 6.28 mm, and the total length of the prism is 29.28 mm.
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    K Number
    K232143
    Device Name
    Applanation Tonometer HT-5000
    Manufacturer
    Huvitz Co., Ltd.
    Date Cleared
    2023-10-23

    (96 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Applanation Tonometer HT-5000 is a manual device intended to measure an intraocular pressure by applanation to aid in the diagnosis of glaucoma. The Applanation Tonometer HT-5000 is indicated for measurement of intraocular pressure (IOP). Intraocular pressure (IOP) is a very important physiological parameter and has always been an indispensable part of the diagnosis and treatment of ophthalmology, especially for glaucoma.
    Device Description
    The Applanation Tonometer HT-5000 is an active medical device, powered by AAA batteries. The device can be used in conjunction with slit lamp microscopes which are commercially available. Components of the tonometer contains applanation tonometer main body, weight bars, connection arms and measuring prisms.
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    K Number
    K220852
    Device Name
    iCare IC200
    Manufacturer
    Icare Finland Oy
    Date Cleared
    2022-10-06

    (197 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iCare IC200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
    Device Description
    The iCare IC200 tonometer (model TA031) is a hand-held, battery-operated device which measures intraocular pressure (IOP) without the need for topical anaesthesia by rebound tonometry. The tonometer is to be used by a healthcare professional. The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP. The measurement method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical with the predicate device. iCare IC200 tonometer can obtain IOP measurements in all angles between horizontal and supine directions. External design has not been modified. The user interface menu has been updated to contain a Quick Measure mode. The new Quick Measure feature is used to measure patient's IOP with fewer rebound measurements and faster measurement cycle. Quick Measure takes two or three rebound measurements; two if both results are within 2 mmHg and third if the difference between the first two measurements is greater than 2 mmHg.
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    K Number
    K211355
    Device Name
    iCare HOME2
    Manufacturer
    Icare Finland Oy
    Date Cleared
    2022-01-25

    (267 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iCare HOME2 tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.
    Device Description
    The iCare HOME2 tonometer (model TA023) is a hand-held, battery operated device which measures intraocular pressure (IOP) without the need for topical anaesthesia by rebound tonometry. The tonometer is to be used by the patients themselves. The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP. The measurement method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical with the predicate device. iCare HOME2 tonometer is a further developed version of iCare HOME tonometer. It features enhancements such as possibility to measure IOP in any angle between 0° and 90° (horizontal to supine patient position) and possibility for wireless measurement result transfer to mobile device or to PC. External design and user interface have been modified for better usability and ergonomics. The measurement data can be uploaded to iCare CLINIC for further analysis using either iCare EXPORT (desktop application) or iCare PATIENT2 (mobile application). iCare PATIENT2 is a mobile app intended for transferring eye pressure measurement data from the iCare tonometer to the iCare CLINIC cloud service or an external system. The app displays the eye pressure measurement results and helps in glaucoma management. It is indicated for use by healthcare professionals and patients. Measurement results can be transferred to iCare CLINIC with either through a Bluetooth connection or by connecting the USB C type connector to the device and mobile phone, depending on the user's mobile phone operating system.
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    K Number
    K203850
    Device Name
    CATS®-D Tonometer Prism
    Manufacturer
    CATS Tonometer LLC
    Date Cleared
    2021-06-14

    (165 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CATS®-D Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.
    Device Description
    The CATS®-D Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. It is made of PMMA, the corneal contact diameter is 6.5 mm and the total length of the prism is 30 mm.
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    K Number
    K200966
    Device Name
    Icare HOME Tonometer
    Manufacturer
    Icare Finland Oy
    Date Cleared
    2020-05-07

    (27 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.
    Device Description
    The Icare HOME tonometer is a home-use handheld, battery operated device that measures the intraocular pressure (IOP) without the need for topical anaesthesia. It is for prescription use only and to be used under the supervision of a healthcare professional. The device is intended to be used by patients at home. The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP. The measurement sequence includes six measurements. The probe moves to the cornea and back during every measurement. The tonometer stores information on every complete measurement sequence of six measurements. The stored information includes the calculated final IOP, time and date of the measurement, identification of the eye (right or left) and the quality level of the measurement (i.e. the standard deviation of the six individual measurements). The measurement data can be uploaded to Icare CLINIC for further analysis using either Icare EXPORT (desktop application) or Icare PATIENT (mobile application). Icare CLINIC is a browser-based software designed for managing patient information and the IOP measurement data.
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    K Number
    K190316
    Device Name
    Icare ic200
    Manufacturer
    Icare Finland Oy
    Date Cleared
    2020-01-14

    (335 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
    Device Description
    The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method, where a small (1.8 mm diameter), light (26.5 mg) probe makes brief contact with the eve. The Icare ic200 probes are sterile (gamma sterilized), single-use accessories of the device. All other accessories of the Icare ic200 are non-sterile and do not have direct patient contact. Icare ic200 allows IOP measurement of patients in all positions between sitting position (direction of probe movement 0°) and supine position (direction of probe movement 90°). Identical to the predicate device, the Icare ic200 (TA031) tonometer records the speed of the probe upon initiation of a measurement sequence. When the moving probe contacts the cornea, the probe decelerates at a rate which depends on the intraocular pressure. The tonometer measures the deceleration of the magnetized probe and the rebound time during contact with the eye and calculates the IOP from these parameters. A single measurement sequence includes six measurements. After the six measurements are completed, the tonometer calculates the final IOP and the result is provided on the display. JOP measurement result can be transferred to printer or to a PC via Bluetooth® connection. The measurement method, the IOP measurement algorithm and rebound technology (including sterile, single-use probe) of Icare ic200 are identical to the predicate device Icare ic100 (TA011, K153694).
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    K Number
    K191314
    Device Name
    Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
    Manufacturer
    Chongqing Sunkingdom Medical Instrument Co., Ltd
    Date Cleared
    2019-12-19

    (218 days)

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

    HKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sunkingdom Applanation Tonometer is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid in the diagnosis of glaucoma.
    Device Description
    Sunkingdom SK-R, SJ-T, SK-Q are applanation tonometers, which are indicated for measurement of intraocular pressure (IOP). Intraocular pressure (IOP) is a very important physiological parameter and has always been an indispensable part of the diagnosis and treatment of ophthalmology, especially for glaucoma. The operation principle is based on Goldmann applanation method, which is considered as the gold standard for measuring intraocular pressure. Therefore the applanation tonometer plays an important role in the diagnosis and treatment of ophthalmic diseases. Sunkingdom series of Applanation tonometer are active medical devices powered by 3V button battery. In practice, it provides two ways to read the measured intraocular pressure value, one from the dial indicator in mmHg unit, the other from the LCD display in mmHg and KPa units. It is used in conjunction with a slit lamp, and the only difference among the SK- R, SK-T, SK-Q is the connection part. Each model differs from each other depending on the type of slit lamp to be used with it as shown in the figure below. All the other technical specifications are the same for these three models. Model SK-Q is especially for the slit lamp with a large head size that cannot be configured for SK-R. Model SK-R can be left on the slit lamp permanently. It is fixed to the microscope on a mounting base and can be rotated in front of the microscope for examination. Model SK-T is mounted on the guide plate over the slit lamp axis for measurement purposes. Components of the tonometer include applanation tonometer main body, Connection mechanical parts and screws, calibration rod, and applanation prism.
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