510(k) · Cleared
ClearedAlcon Series 20000 Legacy Phacoemulsifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · HQC Unit, Phacofragmentation
Cleared on Aug 9, 1995 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 77 later devices descend from it.
- Decided
- Aug 9, 1995
- Review
- 90 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 0
77 later devices descend from it, 6 citing it directly.
- This deviceK952213 Alcon Series 20000 Legacy PhacoemulsifierAlcon Laboratories · 1995
- Descendant · cites it directly · 49 of its ownK993154 Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. · 2000 · Recalled
- Descendant · cites it directly · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- Descendant · 2 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- Descendant · cites it directly · 24 of its ownK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 22 of its ownK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K993154Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. · 2000 · cites it directly49descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · cites it directly47descendants
- K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 2 generations on30descendants
- K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · cites it directly24descendants
- K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952213 | Alcon Series 20000 Legacy Phacoemulsifier | Alcon Laboratories | 1995 | — |
| +1 | K993154 | Laser Photolysis System, Pharo Ophthalmic Surgery System | A.R.C. Laser Corp. | 2000 | 1 |
| +1 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| +2 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| +1 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| +2 | 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 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 8 | 0 |
| 2015 | 7 | 0 |
| 2016 | 2 | 0 |
| 2017 | 10 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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? (77)
See all 776 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993154 | Laser Photolysis System, Pharo Ophthalmic Surgery System | 2000 | 49 |
| K094052 | Lensx 550 Laser System. Model 550 | 2010 | 47 |
| K063331 | Bausch & Lomb NGX Microsurgical System | 2006 | 24 |
| K081877 | Associate 2500 Dual and Compact Systems | 2009 | 8 |
| K974469 | Mentor Phacoemulsification Sistem Remote Control | 1998 | 0 |
| K960024 | Storz D7120 Phaco Handpiece Maintenance Kit & Storz D7125 Phaco Handpiece Needle Wrench | 1996 | 0 |
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, K993154 (A.R.C. Laser Corp., 2000) has gone furthest, with 49 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/K952213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952213: Alcon Series 20000 Legacy Phacoemulsifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952213
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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