Company Elamed
RU Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Intraocular Pressure Tonometer EASYTON Ref K190382
What Company Elamed makes
Company Elamed manufactures the Intraocular Pressure Tonometer EASYTON, a handheld device designed to measure intraocular pressure in ophthalmology for diagnostic purposes.
The device is classified as Class II under FDA regulations and is listed in the FDA 510(k) registry. Company Elamed is based in the United States.
Frequently asked questions
What types of medical devices does Company Elamed manufacture?
Company Elamed specializes in ophthalmology devices, specifically the Intraocular Pressure Tonometer EASYTON. This handheld device is designed to measure intraocular pressure, which is critical for diagnosing and monitoring glaucoma and other eye conditions.
Where is Company Elamed based, and what is its primary focus?
Company Elamed is headquartered in the United States. Its primary focus is on developing and manufacturing diagnostic tools for ophthalmology, with a current emphasis on intraocular pressure measurement.
How are Company Elamed’s devices classified under FDA regulations?
The Intraocular Pressure Tonometer EASYTON, manufactured by Company Elamed, is classified as a Class II device under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness.
Are Company Elamed’s devices listed in any regulatory registries?
Yes, Company Elamed’s Intraocular Pressure Tonometer EASYTON is listed in the FDA’s 510(k) registry. This registry tracks devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.
Information
- Country
- RU