← Product Code [HKI](/productcode/HKI) · K253176 # TearView (K253176) _Beyond 700 Pty, Ltd. · HKI · Jun 22, 2026 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K253176 ## Device Facts - **Applicant:** Beyond 700 Pty, Ltd. - **Product Code:** [HKI](/productcode/HKI.md) - **Decision Date:** Jun 22, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.1120 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Real-World Evidence ## Real-World Evidence | Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags | | --- | --- | --- | --- | --- | --- | | K253176 · Jun 22, 2026 | TearView | Beyond 700 Pty, Ltd. | Clinical practice data from Australian eye clinics; Peer-reviewed clinical literature (Coroneo et al. 2024, Kokkinakis et al. 2023) | The device was evaluated through 4 years of continuous use in real-world clinical settings across more than 1,000 patients to support safety and performance claims. | Real-world use; Clinical practice; Safety surveillance; Ophthalmic imaging | ### Clinical Evidence | Study Design | Population | Comparator | Key Endpoints | | --- | --- | --- | --- | | Field testing in real world use; Observational / Real-world clinical use; Follow-up/Duration: >4 years | Ophthalmic patients; Sample Size: >1,000; Number of Sites: Multiple Australian eye clinics | Not applicable for this study | Safety (adverse events), performance of dynamic emissivity pattern capture | ## Indications for Use TearView is an ophthalmic camera that is intended to be used by an eye care specialist in adult patients to take digital images of the eye and surrounding areas. TearView is a non-contact thermograph that captures and stores images of thermal (emissivity) pattern of the ocular surface including its tear film during blinking. ## Device Story TearView is a non-contact, passive thermal camera accessory for slit lamps; captures long-wave infrared (7.5-13µm) thermal radiation from the ocular surface and tear film during blinking. Device uses a 640x480 microbolometer array; records grey-scale video via touch-screen Windows-based software on a user-provided computer/tablet. Operated by eye care specialists in clinical settings; device attaches to slit lamp turret; slit lamp chin/headrest provides patient alignment. No light source; operates in dark; no direct patient contact. Output allows clinicians to visualize dynamic thermal emissivity patterns of the ocular surface; aids in assessment of tear film dysfunction. Benefits include high-resolution, non-invasive, real-time visualization of ocular surface thermal patterns without environmental control or specific patient blinking requirements. ## Clinical Evidence Bench testing confirmed compliance with ISO 15004-1:2020, IEC 60601-1:2005+A1:2012, and IEC 60601-1-2:2014. Real-world performance testing included over 1,000 patients across 4 years of continuous clinical use. Results published in peer-reviewed literature (Coroneo MT et al., 2024; Kokkinakis J et al., 2023) demonstrate the device safely captures dynamic emissivity patterns of the ocular surface and tear film. ## Technological Characteristics Long-wave infrared (7.5-13µm) thermograph; 640x480 pixel microbolometer array; 30 Hz frame rate; 28mK thermal sensitivity. Fixed focus lens system. Powered via USB-C (5V/5mA). Attaches to slit lamp turret. Software-based image acquisition and storage on external Windows PC/tablet. Complies with ISO 15004-1, IEC 60601-1, and IEC 60601-1-2. ## Regulatory Identification An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area. ## Special Controls *Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Predicate Devices - United Integrated Non-Contact Thermograph System Model IT-85 ([K111771](/device/K111771.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** **U.S. FOOD & DRUG** ADMINISTRATION June 22, 2026 Beyond 700 Pty Ltd Dr. Burkhardt Schuett COO 8 Miller Street Petersham, NSW 2049 Australia Re: K253176 Trade/Device Name: TearView Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: May 9, 2026 Received: May 11, 2026 Dear Burkhardt Schuett: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253176 - Burkhardt Schuett Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K253176 - Burkhardt Schuett Page 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Alexander Beylin Date: 2026.06.22 -S 14:27:17 -04'00' for CAPT Bardley Cunningham, MSE, RAC Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. # Indications for Use 510(k) Number (if known) K253176 Device Name TearView Indications for Use (Describe) TearView is an ophthalmic camera that is intended to be used by an eye care specialist in adult patients to take digital images of the eye and surrounding areas. TearView is a non-contact thermograph that captures and stores images of thermal (emissivity) pattern of the ocular surface including its tear film during blinking. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K253176 # 510(k) SUMMARY | Preparation Date: | 5^{th} June 2026 | | --- | --- | | Applicant: | Beyond 700 Pty Ltd Unit 38 9 Hoyle Avenue Castle Hill, NSW, 2154 Australia | | Contact Person: | Dr Burkhardt Schuett | | Contact Phone | +61 (0) 432 175 797 | | Device Trade Name: | TearView | | Device Version: | Version 3 | | Common Name: | Ophthalmic Imaging Device | | Classification Name: | Camera, Ophthalmic, AC-powered | | Device Classification: | Class II | | Regulation: | 21 CFR 886.1120 | | Predicate Device: | United Integrated Non-Contact Thermograph System Model IT-85 (**K111771**) | | Product Code | HKI | ## 1. Device Description The device TearView is a thermal camera designed to be used for eye conditions that a medical professional considers to have an affect on the thermal (emissivity) pattern of the eye during eye opening and blinking. As such, it is a thermal camera optimized to make recordings of thermal (emissivity) patterns coming off the open eye including its tear film in the blinking process. It is designed as an accessory to a slit lamp (that needs to be provided by the user). It is attached to the turret of a slit lamp via a provided arm. The slit lamp mechanism is used to focus the device on the eye of the patient whose head is supported in the chin / headrest of the slit lamp. TearView is powered by a Windows computer/tablet (not part of the device) via an USB cable connection with a maximum theoretical output of 25mWatt (5V at 5mA). It also receives information from and sends information to the computer/tablet via the same cable connection. TearView is based on a 640×480 pixel array microbolometer with a fixed focus lens system and passively acquires and records the thermal radiation emitted from the ocular surface including its tear film and presents this as a grey-scale video. TearView uses its own touch-screen enabled Windows-based software, which needs to be installed on a computer/tablet (provided by the user) to run the device and to store the recordings for review. The thermal imaging is from a distance and completely passive, hence the device has no light source, can run in the dark, and never contacts the patient directly. Such recordings of unforced normal blinks of a subject take less than 30 seconds and can be taken at any temperature between 20-40°C with no other environmental control or specific blinking of the subject necessary. 1 {5} K253176 ## 2. Indications for Use TearView is an ophthalmic camera that is intended to be used by an eye care specialist in adult patients to take digital images of the eye and surrounding areas. TearView is a non-contact thermograph that captures and stores images of thermal (emissivity) pattern of the ocular surface including its tear film during blinking. ## 3. Substantial Equivalence TearView is similar in principle function to the predicate thermographic camera (see Table 1), however TearView is an improvement on a number of technical parameters that define the effectiveness of this technology. TearView has higher spatial and temperature resolutions as well as a higher frame rate than the predicate device that was previously cleared under K111771. Overall, this is an improvement allowing better and clearer images of the thermal patterns coming from the eye, and as a difference to the Indications for Use statement of the predicate, it was included that the resulting emissivity pattern arise from the ocular surface including the tear film covering the eye as well. Furthermore, TearView is designed as an add-on to a slit lamp and needs an USB connection to an external computer for operation and power-supply rather than being a stand-alone device that is connected to the mains like the predicate. These features do not raise question regarding safety and effectiveness. TearView is not directly connected to the mains, runs on much lower voltage, and does not directly contact the patient. Table 1: Similarities and differences between the proposed device TearView and the predicate device. | | TearView | Predicate, UIS Non-Contact Thermograph System Model IT-85 | Comparison | | --- | --- | --- | --- | | 510(k) Number | K253176 | K111771 | | | Regulation number | 21 CFR 886.1120 | 21 CFR 886.1120 | Identical | | Product code | HKI | HKI | Identical | | Indications for Use | TearView is an ophthalmic camera that is intended to be used by an eye care specialist in adult patients to take digital images of the eye and surrounding areas. TearView is a non-contact thermograph that captures and stores images of thermal (emissivity) patterns of the ocular surface including its tear film during blinking. | The UIS Non-contact Thermograph system is an ophthalmic imaging device that stores, archives, and manipulates digital images of ocular surface temperature measurements taken by a physician in adult patients. | Nearly identical. Both devices capture and store images of thermal emissivity patterns of the ocular surface. TearView and its software do not allow for manipulation of an image that was taken | | Camera Type | Thermograph (Long wave infrared 7.5-13µm) | Thermograph (Long wave infrared 7.5-13µm) | Identical | | Camera Resolution | 640x480 pixel | 320x240 pixel | Not Identical TearView has a higher spatial resolution than the predicate. | 2 {6} K253176 | Camera frame rate | 30 Hz | 30 Hz | Identical | | --- | --- | --- | --- | | Camera sensor noise equivalent temperature (thermal sensitivity) | 28mK | 70mK | Not identical TearView has a higher thermal sensitivity than the predicate | | Recorded media | Digital (external Window-computer or tablet) | Digital (Computer system part of this stand alone device) | Not identical TearView is operated from an external computer | | Contact area with patient | none | Head (chin and forehead) | Not identical TearView is used with a third-party slit-lamp and is not in direct contact with the patient | | Means for alignment | Fixed focus of the camera, for device alignment a slit-lamp mechanism and head rest of that slit lamp is used | Fixed focus of the camera, there are mechanism to move camera and built in head rest as part of this stand alone device | Similar TearView is designed as an add-on to a slit lamp and used the slit lamps function for alignment and focus | | Working distance | 40mm | Not known | | | Light Source | none | none | Identical | | Power Source | USB-C, DC | AC-powered | Not identical | #### 4. Bench Performance and Safety testing TearView complies to the requirements applicable to ophthalmic instruments (ISO 15004-1: 2020) and the standard for basic and electrical safety (IEC 60601-1:2005 + A1:2012). It complies with the standard IEC 60601-1-2: 2014 Part 1+2, set for active devices with regard to electrostatic discharge immunity, radiated field immunity, magnetic field immunity, and unintended emission. The device has been bench tested for its ability to observe the thermal emissivity patterns of the ocular surface including its tear film across a range of ambient temperatures. #### 5. Performance Testing TearView has been field tested in real world use with more than 1,000 ophthalmic patients by 3rd party independent eye care specialists in continuous use for more than 4 years with no adverse events. Some of the resulting real world testing has been published (Coroneo MT et al. High-Resolution Ocular Surface Imaging: Real-Time Visualization of Tear Film Dysfunction. Cornea. 2024 May 30 and Kokkinakis J et al. Effects on the Human Tear Film of Applying Skin Lipids to the Ocular Surface. Cornea. 2023 Dec 1;42:1562-1571). In conclusion, it was shown that TearView enables the dynamic emissivity pattern of ocular surface including its tear film to be captured safely. #### 6. Conclusion The basic and underlying function of the ophthalmic camera TearView is the same as for the predicate. Due to its technical improvements compared to the predicate it allows more detailed thermographic imaging of the eye including its tear film during blinking.. Its use for more than 4 years in Australian eye clinics without any adverse events and the bench performance testing demonstrate that it is as safe and effective as the predicate. Taken together, TearView is therefore substantially equivalent to the predicate device. 3 --- **Source:** [https://fda.innolitics.com/device/K253176](https://fda.innolitics.com/device/K253176) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com