510(k) · Cleared
ClearedPhacotron Gold Multifunction Ultrasonic Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Intraoptics · HQC Unit, Phacofragmentation
Cleared on Jul 29, 1993 after a 262-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 59 later devices descend from it.
- Decided
- Jul 29, 1993
- Review
- 262 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 0
59 later devices descend from it, 3 citing it directly.
- This deviceK925631 Phacotron Gold Multifunction Ultrasonic HandpieceChiron Intraoptics · 1993
- Descendant · cites it directly · 50 of its ownK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- Descendant · 2 generations on · 24 of its ownK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 22 of its ownK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
- Descendant · 3 generations on · 22 of its ownK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K021566InfinitiAlcon Laboratories, Inc. · 2002 · cites it directly50descendants
- K063583Alcon Vision SystemAlcon · 2008 · 2 generations on36descendants
- K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · 2 generations on24descendants
- K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009 · 2 generations on22descendants
- K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925631 | Phacotron Gold Multifunction Ultrasonic Handpiece | Chiron Intraoptics | 1993 | — |
| +1 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| +2 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| +2 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| +2 | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
| +3 | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2017 | 7 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (59)
See all 593 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?
- Of its descendants, K021566 (Alcon Laboratories, Inc., 2002) has gone furthest, with 50 descendants of its own.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K925631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925631: Phacotron Gold Multifunction Ultrasonic Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925631
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026