Cleared Traditional

EASY CONTROL MICRO INSERTER, MODEL ON385

K011498 · Ophtec USA, Inc. · Ophthalmic
Jul 2001
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K011498 is an FDA 510(k) clearance for the EASY CONTROL MICRO INSERTER, MODEL ON385, a Injector, Capsular Tension Ring (Class I — General Controls, product code NCE), submitted by Ophtec USA, Inc. (Boca Raton, US). The FDA issued a Cleared decision on July 9, 2001, 55 days after receiving the submission on May 15, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K011498 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2001
Decision Date July 09, 2001
Days to Decision 55 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code NCE — Injector, Capsular Tension Ring
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300