Cleared Traditional

MONARCH III IOL DELIVERY SYSTEM

K063155 · Alcon Manufacturing, Ltd. · Ophthalmic
Mar 2007
Decision
161d
Days
Class 1
Risk

About This 510(k) Submission

K063155 is an FDA 510(k) clearance for the MONARCH III IOL DELIVERY SYSTEM, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Alcon Manufacturing, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on March 27, 2007, 161 days after receiving the submission on October 17, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K063155 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2006
Decision Date March 27, 2007
Days to Decision 161 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code KYB — Lens, Guide, Intraocular
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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