Tono Vue Non-Contact Tonometer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Non-contact tonometer EUDAMED
- Device Name
- Non-contact Tonometer EUDAMED
- Model / Reference
- TonoVue-P EUDAMEDTonoVue EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876420305 EUDAMED
- Basic UDI-DI
- 471987642TONOMETERGB EUDAMED
- 510(k) Number
- K180820 FDA 510(k)
- FDA Product Code
- HKX FDA 510(k)
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1930 FDA 510(k)
- Regulation Number
- 886.1930 FDA 510(k)
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Tono Vue Non-Contact Tonometer is a Class II medical device designed for measuring intraocular pressure (IOP) in the eye without direct contact with the cornea. It operates using an air-puff technique to assess IOP, a critical parameter in diagnosing and managing glaucoma and other ocular conditions.
This device is supplied as a reusable, AC-powered instrument and is intended for use in ophthalmic clinical settings. It complies with FDA 510(k) clearance and EU MDR regulations, with a registration number of 1000391004. The device is classified under the OpenFDA nomenclature as a Tonometer, Ac-Powered, and is assigned the product code HKX.
Frequently asked questions
How is the Tono Vue Non-Contact Tonometer different from traditional contact tonometers in terms of patient comfort and ease of use?
The Tono Vue Non-Contact Tonometer avoids direct contact with the cornea by using an air-puff technique to measure intraocular pressure (IOP), which eliminates the need for numbing drops or physical contact with the eye. This design reduces patient discomfort and anxiety, especially for those who may be sensitive to touch or have conditions like dry eye. Clinicians benefit from a quicker procedure, as there’s no need to apply gel or wait for anesthesia to take effect, making it ideal for routine screenings or follow-ups.
Is the Tono Vue Non-Contact Tonometer reusable, and if so, what maintenance or cleaning steps are required?
Yes, the Tono Vue is designed as a reusable, AC-powered instrument for clinical use. Since it’s not single-use, proper cleaning and maintenance are essential to ensure accuracy and hygiene. The manufacturer likely provides guidelines for disinfection protocols (e.g., alcohol wipes or UV sterilization) to prevent cross-contamination between patients. Regular calibration checks may also be recommended to maintain measurement precision, though specific cleaning instructions would be detailed in the device’s user manual.
What regulatory pathways has the Tono Vue Non-Contact Tonometer followed, and how does this affect its use in different markets?
The device has undergone FDA 510(k) clearance and complies with EU MDR regulations, with a registration number (1000391004) for the European market. The FDA classification as a Class II device and the EU MDR compliance indicate it meets stringent safety and performance standards for non-contact tonometry. Clinicians in the U.S. can rely on its FDA clearance for use in ophthalmic settings, while EU users can trust its MDR registration for market availability and adherence to EU medical device regulations.
Are there multiple models or sizes of the Tono Vue Non-Contact Tonometer, or is it a single-unit device?
The provided data lists multiple registration numbers (e.g., 3002807782, 3010287677) under the Tono Vue Non-Contact Tonometer, which may correspond to different variants, accessories, or regional adaptations rather than distinct physical models. However, the core device itself is described as a single reusable instrument. For exact specifications on models or accessories, referring to the manufacturer’s documentation or support team would clarify whether additional components (like interchangeable parts or software updates) are available to tailor the device to specific clinical needs.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180820 | Class II | Active |
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Manufacturer
- Manufacturer
- Crystalvue Medical Corporation
Sources (2)
- FDA 510(k) K180820 24 fields · synced Sep 18, 2026
- EUDAMED 15fc19f8-c393-4bbb-9462-0770ee5ca73b 61 fields · synced Jul 25, 2026