510(k) · Cleared
ClearedCATALYS Precision Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amo Manufacturing USA, LLC · OOE Ophthalmic Femtosecond Laser
Cleared on Apr 7, 2021 as substantially equivalent to K200056 (Amo Manufacturng USA, LLC, 2020) after a 29-day review. Its family tree reaches back 18 generations to 1991. 1 later device descends from it.
- Decided
- Apr 7, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K913697 (1991). 63 ancestors in all, the oldest K860001 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 14 generations between
- 3 generations backK172002 Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2017 · Recalled
- 2 generations backK182083 Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2018
- 1 generation backK200056 Catalys Precision Laser SystemAmo Manufacturng USA, LLC · 2020
- This deviceK210701 CATALYS Precision Laser SystemAmo Manufacturing USA, LLC · 2021
- Descendant · cites it directly · 0 of its ownK220516 CATALYS Precision Laser systemAmo Manufacturing USA, LLC · 2022
Show all 18 generations
- Root · 18 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 17 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 16 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 15 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 14 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 13 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 12 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 11 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 10 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 9 generations backK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- 8 generations backK113479 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · Recalled
- 7 generations backK121091 Catalys Precision Laser SystemOptimedica Corporation · 2012 · Recalled
- 6 generations backK141079 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2014 · Recalled
- 5 generations backK161455 Catalys Precision Laser SystemOptimedica Corporation · 2016
- 4 generations backK170322 Catalys Precision Laser SystemAbbott Medical Optics, Inc. · 2017 · Recalled
- 3 generations backK172002 Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2017 · Recalled
- 2 generations backK182083 Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2018
- 1 generation backK200056 Catalys Precision Laser SystemAmo Manufacturng USA, LLC · 2020
- This deviceK210701 CATALYS Precision Laser SystemAmo Manufacturing USA, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −17 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −16 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −15 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −14 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −13 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −12 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −11 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −10 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −9 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| −8 | K113479 | Optimedica Catalys Precision Laser System | Optimedica Corporation | 2011 | 2 |
| −7 | K121091 | Catalys Precision Laser System | Optimedica Corporation | 2012 | 2 |
| −6 | K141079 | Optimedica Catalys Precision Laser System | Optimedica Corporation | 2014 | 3 |
| −5 | K161455 | Catalys Precision Laser System | Optimedica Corporation | 2016 | — |
| −4 | K170322 | Catalys Precision Laser System | Abbott Medical Optics, Inc. | 2017 | 1 |
| −3 | K172002 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2017 | 1 |
| −2 | K182083 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2018 | — |
| −1 | K200056 | Catalys Precision Laser System | Amo Manufacturng USA, LLC | 2020 | — |
| 0 (this device) | K210701 | CATALYS Precision Laser System | Amo Manufacturing USA, LLC | 2021 | — |
| +1 | K220516 | CATALYS Precision Laser system | Amo Manufacturing USA, LLC | 2022 | — |
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 |
|---|---|---|
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K200056 | Catalys Precision Laser SystemSummary page 4…r Product Code: OOE [807.92(a)(3)] Legally Marketed Devices Predicate Device: CATALYS® Precision Laser System (K200056, May 18, 2020) [807.92(a)(4)] Device Description Device Description: Catalys® Precision Laser System ophthalmic surg… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220516 | CATALYS Precision Laser system | 2022 | 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?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 63 ancestors have a recall of any class.
- Of its descendants, K220516 (Amo Manufacturing USA, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200056.
How does its category compare?
All OOE devicesOOE Ophthalmic Femtosecond Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 CATALY S® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210701: CATALYS Precision Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210701
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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