Cleared Traditional

MONARCH IOL DELIVERY SYSTEM

K970033 · Alcon Laboratories · Ophthalmic
Apr 1997
Decision
110d
Days
Class 1
Risk

About This 510(k) Submission

K970033 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 April 23, 1997, 110 days after receiving the submission on January 3, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K970033 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1997
Decision Date April 23, 1997
Days to Decision 110 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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