510(k) · Cleared
ClearedCenturion™ Vision System (Active Sentry™) (8065753057)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · HQC Unit, Phacofragmentation
Cleared on Jan 10, 2024 as substantially equivalent to K161794 (Alcon Research, Ltd., 2017) after a 30-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Jan 10, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K933880 (1994). 60 ancestors in all, the oldest K842458 (1984). No later device cites it as a predicate yet.
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 5 generations between
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- 1 generation backK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
- This deviceK233902 Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 8 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 7 generations backK964074 Diolite 532Iriderm Div. · 1997
- 6 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 5 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 4 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- 1 generation backK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
- This deviceK233902 Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −8 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −7 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −6 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −5 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −4 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −3 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −2 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| −1 | K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017 | — |
| 0 (this device) | K233902 | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories, Inc. | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K161794 | CENTURION Vision System (Active SentryTM)Summary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K161794 CENTURION T M Vision System (Active SentryTM ) ZHQC LDevice Descri… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 17 of the 60 ancestors have a recall of any class.
- 2 other devices also cite its predicate K161794.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 CenturionTM 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-T r IOL Injector Handpiece is intended to deliver qualified AcrySof T M intraocular lenses into the eye following cataract removal.…
Read the full statement (117 words)
The CenturionTM 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-T r IOL Injector Handpiece is intended to deliver qualified AcrySof T M
intraocular lenses into the eye following cataract removal.
The AutoSert-Tr IOL Injector Handpiece achieves the functionality of injection of intraocular lenses.
The AutoSert-T r IOL Injector Handpiece is indicated for use with AcrySof TM lenses SN60WF,
SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof TM lenses that are specifically
indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233902: Centurion™ Vision System (Active Sentry™) (8065753057).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233902
Report an extraction error
Are you the manufacturer?
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