Cleared Traditional

Intraocular Pressure Tonometer EASYTON

K190382 · Company Elamed · Ophthalmic

Dec 2019

Decision

290d

Days

Class 2

Risk

About This 510(k) Submission

K190382 is an FDA 510(k) clearance for the Intraocular Pressure Tonometer EASYTON, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Company Elamed (Yelatma, RU). The FDA issued a Cleared decision on December 6, 2019, 290 days after receiving the submission on February 19, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K190382 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2019
Decision Date	December 06, 2019
Days to Decision	290 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF