510(k) · Cleared
Recalled · Class II · 2018Catalys Precision Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optimedica Corporation · OOE Ophthalmic Femtosecond Laser
Cleared on Aug 28, 2012 as substantially equivalent to K113479 (Optimedica Corporation, 2011) after a 140-day review. Its family tree reaches back 11 generations to 1991. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 28, 2012
- Review
- 140 days
- Class
- Class II
- Product code
- OOE
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913697 (1991). 56 ancestors in all, the oldest K860001 (1986). 12 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 7 generations between
- 3 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 2 generations backK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- 1 generation backK113479 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · Recalled
- This deviceK121091 Catalys Precision Laser SystemOptimedica Corporation · 2012
- Descendant · cites it directly · 8 of its ownK141079 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2014 · Recalled
- Descendant · 2 generations on · 7 of its ownK161455 Catalys Precision Laser SystemOptimedica Corporation · 2016
- Descendant · 3 generations on · 6 of its ownK170322 Catalys Precision Laser SystemAbbott Medical Optics, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 5 of its ownK172002 Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2017 · Recalled
- Descendant · 5 generations on · 4 of its ownK182083 Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2018
Show all 11 generations
- Root · 11 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 10 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 9 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 8 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 7 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 6 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 5 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 4 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 3 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 2 generations backK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- 1 generation backK113479 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · Recalled
- This deviceK121091 Catalys Precision Laser SystemOptimedica Corporation · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K141079Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2014 · cites it directly8descendants
- K161455Catalys Precision Laser SystemOptimedica Corporation · 2016 · 2 generations on7descendants
- K170322Catalys Precision Laser SystemAbbott Medical Optics, Inc. · 2017 · 3 generations on6descendants
- K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2017 · 4 generations on5descendants
- K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2018 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −10 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −9 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −8 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −7 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −6 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −5 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −4 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −3 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −2 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| −1 | K113479 | Optimedica Catalys Precision Laser System | Optimedica Corporation | 2011 | 2 |
| 0 (this device) | K121091 | Catalys Precision Laser System | Optimedica Corporation | 2012 | — |
| +1 | K141079 | Optimedica Catalys Precision Laser System | Optimedica Corporation | 2014 | 3 |
| +2 | K161455 | Catalys Precision Laser System | Optimedica Corporation | 2016 | — |
| +3 | K170322 | Catalys Precision Laser System | Abbott Medical Optics, Inc. | 2017 | 1 |
| +4 | K172002 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2017 | 1 |
| +5 | K182083 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 OOE? 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 OOE device
- #1 K243896 LenSx Laser System (8065998162)score 16.7 · 16 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113479 | Optimedica Catalys Precision Laser SystemSummary page 1…er 5.1.5. Trade Name OptiMedica@ CatalysTM Precision Laser System 5.1.6. Predicate Devices *OptiMedica CatalySTM Precision Laser System; KL113479 *LenSx Laser System (Alcon Corporation); K1O01626 5.1.7. Intended Use The OptiMedica® CatalySTM Precision… | 2011 |
| Kept off the family tree | K1001626 | LenSx Laser System (Alcon Corporation) Number could not be read |
What descends from it? (12)
See all 122 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2018 | Class II | Z-0066-2019 | Device Design | Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI. |
| Dec 20, 2013 | Class II | Z-0649-2014 | Under Investigation by firm | Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 56 ancestors have a recall of any class.
- Of its descendants, K141079 (Optimedica Corporation, 2014) has gone furthest, with 8 descendants of its own.
How does its category compare?
All OOE devicesOOE Ophthalmic Femtosecond Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OOE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OOE
129in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OOE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOE
438in 2025
MAUDE reports naming product code OOE, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 131 | 0 | 0 |
| 2011 | 4 | 132 | 0 | 10 |
| 2012 | 4 | 138 | 0 | 74 |
| 2013 | 2 | — | 1 | 164 |
| 2014 | 4 | 133 | 0 | 264 |
| 2015 | 5 | 151 | 0 | 689 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 6 | 81 | 0 | 483 |
| 2018 | 5 | 99 | 1 | 434 |
| 2019 | 0 | — | 0 | 311 |
| 2020 | 2 | — | 0 | 199 |
| 2021 | 1 | — | 1 | 328 |
| 2022 | 3 | 129 | 0 | 204 |
| 2023 | 2 | — | 0 | 231 |
| 2024 | 0 | — | 0 | 325 |
| 2025 | 2 | — | 0 | 438 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OptiMedica®)CatalysM Precision Laser System is indicated for
use in patients undergoing cataract surgery for removal of the crystalline
lens. Intended uses in cataract surgery include anterior capsulotomy,
phacofragmentation, and the creation of single plane and multi-plane
arc cuts/incisions in the cornea, each of which may be performed
either individually or consecutively during the same procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121091 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121091: Catalys Precision Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121091
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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