Cleared Traditional

Tono Vue Non-Contact Tonometer

K180820 · Crystalvue Medical Corporation · Ophthalmic

Dec 2018

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K180820 is an FDA 510(k) clearance for the Tono Vue Non-Contact Tonometer, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Crystalvue Medical Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on December 14, 2018, 260 days after receiving the submission on March 29, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K180820 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2018
Decision Date	December 14, 2018
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF