510(k) · Cleared
ClearedAqualase Capsule Wash Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Manufacturing, Ltd. · HQC Unit, Phacofragmentation
Cleared on Mar 4, 2010 as substantially equivalent to K980292 (Alcon Laboratories, 1998) and 2 other predicates after a 142-day review. Its family tree reaches back 3 generations to 1985. 9 later devices descend from it.
- Decided
- Mar 4, 2010
- Review
- 142 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K844373 (1985). 18 ancestors in all, the oldest K842458 (1984). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 2 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 1 generation backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- This deviceK093210 Aqualase Capsule Wash TipAlcon Manufacturing, Ltd. · 2010
- Descendant · cites it directly · 8 of its ownK112425 Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011
- Descendant · 2 generations on · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 3 of its ownK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK120912 Infiniti (R) Vision SystemAlcon Manufacturing, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK141065 Constellation Vision SystemAlcon Research, Ltd. · 2014 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K112425Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011 · cites it directly8descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · 2 generations on6descendants
- K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017 · 3 generations on3descendants
- K120912Infiniti (R) Vision SystemAlcon Manufacturing, Ltd. · 2012 · cites it directly3descendants
- K141065Constellation Vision SystemAlcon Research, Ltd. · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −2 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −1 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| 0 (this device) | K093210 | Aqualase Capsule Wash Tip | Alcon Manufacturing, Ltd. | 2010 | — |
| +1 | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece | Alcon Manufacturing, Ltd. | 2011 | — |
| +2 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +3 | K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017 | — |
| +1 | K120912 | Infiniti (R) Vision System | Alcon Manufacturing, Ltd. | 2012 | 1 |
| +2 | K141065 | Constellation Vision System | Alcon Research, Ltd. | 2014 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 13.5 · 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980292 | Cataract Liquefracture DeviceSummary page 1…1 CFR 886.4670) Predicate Devices The legally marketed devices(s) to which we are claiming equivalence to are: 51()Number Device K980292/K021 566 AquaL-ase® 1.1 mm Liquefaction Tip Kg9I1808/K910245 ALCON® Silicone I/A Tip K030957 Milveila… | 1998 |
| * | K021566 | InfinitiSummary page 1…CFR 886.4670) Predicate Devices The legally marketed devices(s) to which we are claiming equivalence to are: 51()Number Device K980292/K021 566 AquaL-ase® 1.1 mm Liquefaction Tip Kg9I1808/K910245 ALCON® Silicone I/A Tip K030957 Milveila Perfect c… | 2002 |
| Kept off the family tree | K891808 | FDA’s K891808 is Patient Examination Gloves (Latex) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1989 |
| Kept off the family tree | K910245 | FDA’s K910245 is I/a Handpiece with Replaceable Tips Our reading of the summary gave K910245, FDA’s number for I/a Handpiece with Replaceable Tips (Surgical Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ALCON® Silicone I/A Tip”. Kept off the family tree. Summary page 1…egally marketed devices(s) to which we are claiming equivalence to are: 51()Number Device K980292/K021 566 AquaL-ase® 1.1 mm Liquefaction Tip Kg9I1808/K910245 ALCON® Silicone I/A Tip K030957 Milveila Perfect capsule… | 1991 |
| * | K030957 | Perfect CapsuleSummary page 1…are claiming equivalence to are: 51()Number Device K980292/K021 566 AquaL-ase® 1.1 mm Liquefaction Tip Kg9I1808/K910245 ALCON® Silicone I/A Tip K030957 Milveila Perfect capsule PAGE 1 0F 4… | 2003 |
What descends from it? (9)
2 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 25 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 6 of the 18 ancestors have a recall of any class.
- Of its descendants, K112425 (Alcon Manufacturing, Ltd., 2011) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K980292.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 AquaLase® Capsule Wash Tip is indicated to assist in the removal of residual cortical material and lens epithelial cells.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093210 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093210: Aqualase Capsule Wash Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093210
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