Intraocular Pressure Tonometer EASYTON

FDA 510(k) K190382 · Company Elamed

Substantially Equivalent

510(k) numberK190382

Submission

Device name
Intraocular Pressure Tonometer EASYTON
Applicant
Company Elamed
Yelatma, RU
Received
February 19, 2019
Decision date
December 6, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HKX – Tonometer, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1930
Specialty
Ophthalmic

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Questions and answers

When was Intraocular Pressure Tonometer EASYTON cleared by the FDA?

Intraocular Pressure Tonometer EASYTON (K190382) received a 510(k) decision of Substantially Equivalent on December 6, 2019, 290 days after the submission was received.

What is the product code of K190382?

The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.