Cleared Abbreviated

K003768 - MONARCH II IOL DELIVERY SYSTEM

K003768 is an FDA 510(k) clearance for MONARCH II IOL DELIVERY SYSTEM, manufactured by Alcon Research, Ltd.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Abbreviated 510(k) pathway after a 30-day FDA review.

K003768 · Alcon Research, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
30d
Days
Class 1
Risk

K003768 is an FDA 510(k) clearance for the MONARCH II IOL DELIVERY SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on January 5, 2001 after a review of 30 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alcon Research, Ltd. devices

FDA 510(k) Submission Details - K003768

510(k) Number K003768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date January 05, 2001
Days to Decision 30 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Standards-based clearance path.

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 42
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K003768.
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LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
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FOAM TIP INJECTOR
K980696 · Staar Surgical Co. · Sep 1998
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K970727 · Chiron Vision Corp. · Dec 1997