510(k) · Cleared
ClearedCENTURION Vision System (Active SentryTM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Research, Ltd. · HQC Unit, Phacofragmentation
Cleared on Apr 14, 2017 as substantially equivalent to K121555 (Alcon Laboratories, Inc., 2012) after a 288-day review. Its family tree reaches back 8 generations to 1994. 3 later devices descend from it.
- Decided
- Apr 14, 2017
- Review
- 288 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K933880 (1994). 59 ancestors in all, the oldest K842458 (1984). 3 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 7 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 6 generations backK964074 Diolite 532Iriderm Div. · 1997
- 5 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 4 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 3 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 2 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 1 generation backK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- This deviceK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK233876 Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK233902 Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK191650 LEGION SystemAlcon Research, LLC · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024 · cites it directly0descendants
- K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc. · 2024 · cites it directly0descendants
- K191650LEGION SystemAlcon Research, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −7 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −6 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −5 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −4 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −3 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −2 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −1 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| 0 (this device) | K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017 | — |
| +1 | K233876 | Unity VCS (8065000296); Unity CS (8065000297) | Alcon Laboratories, Inc. | 2024 | 2 |
| +1 | K233902 | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories, Inc. | 2024 | — |
| +1 | K191650 | LEGION System | Alcon Research, LLC | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121555 | Centurion Vision SystemSummary page 4…n Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC A. Predicate Device CENTURION Vision System K121555 December 21, 2012 B. Device Description Alcon’s CENTURION ® Vision System is an ophthalmic surgical instrument designed for use… | 2012 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 17 of the 59 ancestors have a recall of any class.
- Of its descendants, K233876 (Alcon Laboratories, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121555.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
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…
Read the full statement (114 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161794: CENTURION Vision System (Active SentryTM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161794
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026