Cleared Traditional

MONARCH II IOL DELIVERY SYSTEM

K001157 · Alcon Research, Ltd. · Ophthalmic
Jun 2000
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K001157 is an FDA 510(k) clearance for the MONARCH II IOL DELIVERY SYSTEM, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on June 27, 2000, 78 days after receiving the submission on April 10, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K001157 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2000
Decision Date June 27, 2000
Days to Decision 78 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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