510(k) · Cleared
ClearedAmo Diplomax/Opsys Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan, Inc. · HQC Unit, Phacofragmentation
Cleared on Jun 13, 1997 after a 73-day review. The FDA summary names its predicate without a number. 60 later devices descend from it.
- Decided
- Jun 13, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 1 citing it directly.
- This deviceK971186 Amo Diplomax/Opsys ConsoleAllergan, Inc. · 1997
- Descendant · cites it directly · 59 of its ownK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 50 of its ownK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- Descendant · 3 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
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K981116Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · cites it directly59descendants
- K021566InfinitiAlcon Laboratories, Inc. · 2002 · 2 generations on50descendants
- K063583Alcon Vision SystemAlcon · 2008 · 2 generations on36descendants
- K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · 3 generations on24descendants
- K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 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) | K971186 | Amo Diplomax/Opsys Console | Allergan, Inc. | 1997 | — |
| +1 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| +2 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| +2 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| +3 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| +2 | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 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), 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? (2)
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 |
|---|---|---|---|
| * | — | AMO®Diplomax™ console Named without a submission number | |
| * | — | AMO®Opsys® console Named without a submission number |
What descends from it? (60)
See all 601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981116 | Sovereign Cataract Extraction System | 1998 | 59 |
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, K981116 (Allergan, Inc., 1998) has gone furthest, with 59 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 | — |
What is it indicated for?
The AMO®Diplomax™ and AMO®Opsys® consoles are components of phacofragmentation systems designed to provide all the surgical capabilities desired by the Anterior Segment/Cataract Surgeon. Phacofragmentation, also known as phacoemulsification or “phaco,” is a cataract removal technique. When utilizing this technique, the surgeon makes a small incision in the eye and breaks up the cataract using ultrasonic vibration delivered by the tip of the handpiece inserted through the incision.
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/K971186 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971186: Amo Diplomax/Opsys Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971186
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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