Cleared Traditional

K161794 - CENTURION Vision System (Active SentryTM)

K161794 is the FDA 510(k) clearance for CENTURION Vision System (Active SentryTM) by Alcon Research, Ltd.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K161794 · Alcon Research, Ltd. · Ophthalmic device
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Apr 2017
Decision
288d
Days
Class 2
Risk

K161794 is an FDA 510(k) clearance for the CENTURION Vision System (Active SentryTM). Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on April 14, 2017 after a review of 288 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Alcon Research, Ltd. devices

Submission Details

510(k) Number K161794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2016
Decision Date April 14, 2017
Days to Decision 288 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
178d slower than avg
Panel avg: 110d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

All 81
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K161794.
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K190875 · D.O.R.C. Dutch Ophthalmic Research Center (International) · Sep 2019
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K191024 · Carl Zeiss Meditec Cataract Technology, Inc. · Aug 2019
CENTURION VISION SYSTEM
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