Cleared Traditional

MONARCH III IOL DELIVERY SYSTEM (K063155) - FDA 510(k) Clearance

Class I Ophthalmic device.

K063155 · Alcon Manufacturing, Ltd. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
161d
Days
Class 1
Risk

K063155 is an FDA 510(k) clearance for the MONARCH III IOL DELIVERY SYSTEM. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Alcon Manufacturing, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on March 27, 2007 after a review of 161 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Alcon Manufacturing, Ltd. devices

Submission Details

510(k) Number K063155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 110d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYB Lens, Guide, Intraocular
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.