Cleared Traditional

MONARCH IOL DELIVERY SYSTEM

K981571 · Alcon Laboratories · Ophthalmic
Jul 1998
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K981571 is an FDA 510(k) clearance for the MONARCH IOL DELIVERY SYSTEM, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on July 9, 1998, 66 days after receiving the submission on May 4, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K981571 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1998
Decision Date July 09, 1998
Days to Decision 66 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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