# K161794: CENTURION Vision System (Active SentryTM)

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Research, Ltd.
- Decided: Apr 14, 2017 after 288 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933880 (1994). 59 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121555: Centurion Vision System, Alcon Laboratories, Inc. (2012) Summary page 4.

## Most influential descendants
- K233876: Unity VCS (8065000296); Unity CS (8065000297) (2024), 0 descendants of its own
- K233902: Centurion™ Vision System (Active Sentry™) (8065753057) (2024), 0 descendants of its own
- K191650: LEGION System (2019), 0 descendants of its own

## Indications for use
The CENTURION® Vision system (Active SentryTM) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert IOL Injector Handpiece is intended to deliver qualified ACRY SOF intraocular lenses into the eye following cataract removal. The AutoSert IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the ACRY SOF lenses SN6OWF, SNWADI, SN6AT3 through SN6AT9, as well as approved ACRY SOF lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Source page: https://510kreport.com/device/K161794
Methodology: https://510kreport.com/methodology