Cleared Traditional

K101774 - MONARCH III IOL DELIVERY SYSTEM

Also marketed or referenced as:
MONARCH III P CATRIDGE MONARCH III HANDPIECE (H4)

K101774 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 MSS cleared through the Traditional 510(k) pathway after a 476-day FDA review.

K101774 · Alcon Manufacturing, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
476d
Days
Class 1
Risk

K101774 is an FDA 510(k) clearance for the MONARCH III IOL DELIVERY SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Alcon Manufacturing, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on October 13, 2011 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Alcon Manufacturing, Ltd. devices

FDA 510(k) Submission Details - K101774

510(k) Number K101774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2010
Decision Date October 13, 2011
Days to Decision 476 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
366d slower than avg
Panel avg: 110d · This submission: 476d
Pathway characteristics
Predicate-based equivalence.

MSS Device Classification - Class 1, General Controls

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.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 23
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K101774.
Bausch + Lomb Injector System
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BAUSCH & LOMB IOL INJECTOR
K113852 · Bausch & Lomb, Inc. · Sep 2012
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
K112977 · Alcon Research, Ltd. · Mar 2012
EPIPHANY INJECTION SYSTEM
K090161 · Staar Surgical Co. · Jun 2009
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · Bausch & Lomb, Inc. · Oct 2008
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K073586 · Staar Surgical Co. · Mar 2008