Cleared Special

K233902 - Centurion™ Vision System (Active Sentry™) (8065753057) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233902 · Alcon Laboratories, Inc. · Ophthalmic device
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Jan 2024
Decision
30d
Days
Class 2
Risk

K233902 is an FDA 510(k) clearance for the Centurion™ Vision System (Active Sentry™) (8065753057). Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on January 10, 2024 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alcon Laboratories, Inc. devices

Submission Details

510(k) Number K233902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2023
Decision Date January 10, 2024
Days to Decision 30 days
Submission Type Special
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
Modification to existing cleared device.

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 314
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