510(k) · Cleared
ClearedAmo Whitestar Signature Phacoemulsification System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical Optics, Inc. · HQC Unit, Phacofragmentation
Cleared on Sep 27, 2011 as substantially equivalent to K060366 (Advanced Medical Optics, Inc., 2006) after a 102-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Sep 27, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911808 (1991). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK911808 Gemini Ophthalmic Surgery SystemAlcon Laboratories · 1991 · Recalled
- 1 generation backK060366 The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 2006 · Recalled
- This deviceK111697 Amo Whitestar Signature Phacoemulsification SystemAbbott Medical Optics, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK151636 AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR…Abbott Medical Optics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK203060 VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack…Johnson & Johnson Surgical Vision, Inc. · 2021 · Recalled
Most influential descendants
Showing 2 of 2 · See all- K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance…Abbott Medical Optics, Inc. · 2015 · cites it directly1descendant
- K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced…Johnson & Johnson Surgical Vision, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911808 | Gemini Ophthalmic Surgery System | Alcon Laboratories | 1991 | 2 |
| −1 | K060366 | The Amo Ophthalmic Surgical System | Advanced Medical Optics, Inc. | 2006 | 1 |
| 0 (this device) | K111697 | Amo Whitestar Signature Phacoemulsification System | Abbott Medical Optics, Inc. | 2011 | — |
| +1 | K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature… | Abbott Medical Optics, Inc. | 2015 | — |
| +2 | K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and… | Johnson & Johnson Surgical Vision, Inc. | 2021 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K060366 | The Amo Ophthalmic Surgical SystemSummary page 1…bstantial equivalence is claimed: 610() Cearace evic Maufacure Number Dat K060366 April 7, 2006 Device Name: The AMO Abbott Medical Optics Ophthalmic… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance… | 2015 | 1 |
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 20 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K151636 (Abbott Medical Optics, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K060366.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 AMO WHITESTAR Signature Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.
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/K111697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111697: Amo Whitestar Signature Phacoemulsification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111697
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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