Cleared Traditional

Sensor Medical Single Use Tonometer Prism

K152308 · Sensor Medical Technology, LLC · Ophthalmic
Oct 2015
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K152308 is an FDA 510(k) clearance for the Sensor Medical Single Use Tonometer Prism, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Sensor Medical Technology, LLC (Maple Valley, US). The FDA issued a Cleared decision on October 13, 2015, 60 days after receiving the submission on August 14, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K152308 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2015
Decision Date October 13, 2015
Days to Decision 60 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKY — Tonometer, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930