Cleared Abbreviated

K110166 - CLEARCUT S SAFETY KNIFE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K110166 · Alcon Research, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
120d
Days
Class 1
Risk

K110166 is an FDA 510(k) clearance for the CLEARCUT S SAFETY KNIFE. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on May 20, 2011 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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

Submission Details

510(k) Number K110166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2011
Decision Date May 20, 2011
Days to Decision 120 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code HNN Knife, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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.