510(k) · Cleared
ClearedELITA™ Femtosecond Laser System, ELITA™ Patient Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Surgical Vision, Inc. · OOE Ophthalmic Femtosecond Laser
Cleared on Apr 14, 2023 as substantially equivalent to K213559 (Sie Ag,Surgical Instrument Engineering, 2022) and 1 other predicate after a 136-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Apr 14, 2023
- Review
- 136 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K913697 (1991). 69 ancestors in all, the oldest K822112 (1982). No later device cites it as a predicate yet.
- Root · 14 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 10 generations between
- 3 generations backK121091 Catalys Precision Laser SystemOptimedica Corporation · 2012 · Recalled
- 2 generations backK150323 FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering · 2015 · Recalled
- 1 generation backK213559 FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering · 2022
- This deviceK223566 ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc. · 2023
Show all 14 generations
- Root · 14 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 13 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 12 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 11 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 10 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 9 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 8 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 7 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 6 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 5 generations backK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- 4 generations backK113479 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · Recalled
- 3 generations backK121091 Catalys Precision Laser SystemOptimedica Corporation · 2012 · Recalled
- 2 generations backK150323 FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering · 2015 · Recalled
- 1 generation backK213559 FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering · 2022
- This deviceK223566 ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −13 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −12 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −11 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −10 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −9 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −8 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −7 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −6 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −5 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| −4 | K113479 | Optimedica Catalys Precision Laser System | Optimedica Corporation | 2011 | 2 |
| −3 | K121091 | Catalys Precision Laser System | Optimedica Corporation | 2012 | 2 |
| −2 | K150323 | FEMTO LDV Z8 Surgical Laser | Sie Ag,Surgical Instrument Engineering | 2015 | 1 |
| −1 | K213559 | FEMTO LDV Z8 Femtosecond Surgical Laser | Sie Ag,Surgical Instrument Engineering | 2022 | — |
| 0 (this device) | K223566 | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | Johnson & Johnson Surgical Vision, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 3 | 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 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 16.8 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213559 | FEMTO LDV Z8 Femtosecond Surgical LaserSummary page 4…roduct Code: OOE [807.92(a)(3)] Legally Marketed Devices Primary Predicate: Femto LDV Z8 Femtosecond Surgical Laser - K213559, Cleared April 21, 2022 (specific to Regulation # 886.4390) Secondary Predicate: iFS Advance… | 2022 |
| * | K141852 | Ifs Advanced Femtosecond Laser SystemSummary page 4…r - K213559, Cleared April 21, 2022 (specific to Regulation # 886.4390) Secondary Predicate: iFS Advanced Femtosecond Laser System - K141852; cleared January 16, 2015 (specific to intended use and technology)… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 14 of the 69 ancestors have a recall of any class.
How does its category compare?
All OOE devicesOOE Ophthalmic Femtosecond Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223566 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223566: ELITA™ Femtosecond Laser System, ELITA™ Patient Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223566
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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