Cleared Abbreviated

K003768 - MONARCH II IOL DELIVERY SYSTEM

K003768 is the FDA 510(k) clearance for MONARCH II IOL DELIVERY SYSTEM by Alcon Research, Ltd.. It is a Class 1 Ophthalmic device (product code MSS) cleared through the Abbreviated 510(k) pathway after a 30-day FDA review.

K003768 · Alcon Research, Ltd. · Ophthalmic device
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Jan 2001
Decision
30d
Days
Class 1
Risk

K003768 is an FDA 510(k) clearance for the MONARCH II IOL DELIVERY SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on January 5, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alcon Research, Ltd. devices

Submission Details

510(k) Number K003768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date January 05, 2001
Days to Decision 30 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.