Cleared Traditional

MONARCH III IOL DELIVERY SYSTEM (K101774) - FDA 510(k) Clearance

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

Class I Ophthalmic device.

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

Submission Details

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.

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.

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

All 61
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