Cleared Traditional

K001157 - MONARCH II IOL DELIVERY SYSTEM (FDA 510(k) Clearance)

Class I Ophthalmic device.

K001157 · Alcon Research, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
78d
Days
Class 1
Risk

K001157 is an FDA 510(k) clearance for the MONARCH II IOL DELIVERY SYSTEM. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on June 27, 2000 after a review of 78 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alcon Research, Ltd. devices

Submission Details

510(k) Number K001157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date June 27, 2000
Days to Decision 78 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
32d faster than avg
Panel avg: 110d · This submission: 78d
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.