Intraocular Pressure Tonometer Easyton
by Company Elamed Russia 510(k)
510(k) K190382
Product code HKX
Overview
The Intraocular Pressure Tonometer Easyton is an ac-powered, handheld digital tonometer designed for measuring intraocular pressure (IOP) in ophthalmic and optometric settings. Classified as a tonometer, this device is intended for non-contact or transpalpebral measurement of IOP, aiding in the diagnosis and monitoring of conditions such as glaucoma. Its digital readout provides precise and repeatable measurements, supporting clinical decision-making in eye care.
The Easyton is supplied as a reusable, portable device intended for use in clinical environments, including ophthalmology and optometry practices. It operates in electromagnetic environments and is manufactured in compliance with regulatory standards, including FDA 510(k) clearance (K190382) under the Ophthalmic Advisory Committee. The device is not single-use and requires proper calibration and maintenance as specified in its technical documentation. Storage and handling follow standard medical device protocols to ensure accuracy and reliability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190382 | Date6 Dec 2019 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1930
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Easyton Intraocular Pressure Tonometer used for?
The Easyton Intraocular Pressure Tonometer is designed for measuring intraocular pressure (IOP) in clinical settings like ophthalmology and optometry. It supports non-contact or transpalpebral measurement, helping diagnose and monitor conditions such as glaucoma by providing accurate and repeatable digital readings for clinical decision-making.
Is the Easyton tonometer single-use or reusable?
The Easyton is a reusable device, built for portability and repeated use in clinical environments. Since it is not single-use, proper calibration and maintenance—following the manufacturer’s technical documentation—are essential to ensure consistent accuracy and reliability over time.
How is the Easyton tonometer supplied and stored?
The Easyton is supplied as a standalone, reusable handheld unit intended for use in clinical settings. Storage and handling must follow standard medical device protocols to preserve its performance. The device requires electromagnetic compatibility and should be stored in a clean, dry environment away from extreme temperatures or direct sunlight.
Does the Easyton require any special maintenance or calibration?
Yes, the Easyton is not self-calibrating and requires periodic calibration to maintain measurement accuracy. The manufacturer provides technical documentation outlining calibration procedures, which should be followed as part of routine device maintenance to ensure reliable intraocular pressure readings.
What regulatory approval does the Easyton Intraocular Pressure Tonometer hold?
The Easyton has received FDA 510(k) clearance (K190382) under the Ophthalmic Advisory Committee, confirming it is substantially equivalent to a legally marketed predicate device. This approval ensures compliance with U.S. regulatory standards for its intended use in measuring IOP.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K190382