Cleared Traditional

CORVIS ST

K113066 · Oculus Optikgerate GmbH · Ophthalmic
Nov 2012
Decision
388d
Days
Class 2
Risk

About This 510(k) Submission

K113066 is an FDA 510(k) clearance for the CORVIS ST, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Oculus Optikgerate GmbH (Wetzlar, DE). The FDA issued a Cleared decision on November 8, 2012, 388 days after receiving the submission on October 17, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K113066 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2011
Decision Date November 08, 2012
Days to Decision 388 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKX — Tonometer, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930

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