Cleared Traditional

K063155 - MONARCH III IOL DELIVERY SYSTEM

K063155 is an FDA 510(k) clearance for MONARCH III IOL DELIVERY SYSTEM, manufactured by Alcon Manufacturing, Ltd.. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K063155 · Alcon Manufacturing, Ltd. · Ophthalmic device
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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

FDA 510(k) Submission Details - K063155

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.

KYB Device Classification - Class 1, General Controls

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.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 18
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K063155.
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MONARCH IOL DELIVERY SYSTEM
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MONARCH IOL DELIVERY SYSTEM
K970033 · Alcon Laboratories · Apr 1997
ACRYPAK FOLDER
K965185 · Alcon Laboratories · Mar 1997