510(k) · Cleared
ClearedLenSx Laser System (8065000944)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · OOE Ophthalmic Femtosecond Laser
Cleared on Sep 24, 2025 as substantially equivalent to K243896 (Alcon Laboratories, Inc., 2025) after a 30-day review. Its family tree reaches back 17 generations to 1991.
- Decided
- Sep 24, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K913697 (1991). 95 ancestors in all, the oldest P810005 (1981). No later device cites it as a predicate yet.
- Root · 17 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 13 generations between
- 3 generations backK163551 LenSx Laser SystemAlcon Laboratories, Inc. · 2017
- 2 generations backK173660 LenSx Laser SystemAlcon Laboratories, Inc. · 2018
- 1 generation backK243896 LenSx Laser System (8065998162)Alcon Laboratories, Inc. · 2025
- This deviceK252682 LenSx Laser System (8065000944)Alcon Laboratories, Inc. · 2025
Show all 17 generations
- Root · 17 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 16 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 15 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 14 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 13 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 12 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 11 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 10 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 9 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 8 generations backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 7 generations backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- 6 generations backK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · Recalled
- 5 generations backK123120 Lensx Laser SystemAlcon Lensx, Inc. · 2012
- 4 generations backK161288 LenSX Laser SystemAlcon Laboratories, Inc. · 2016
- 3 generations backK163551 LenSx Laser SystemAlcon Laboratories, Inc. · 2017
- 2 generations backK173660 LenSx Laser SystemAlcon Laboratories, Inc. · 2018
- 1 generation backK243896 LenSx Laser System (8065998162)Alcon Laboratories, Inc. · 2025
- This deviceK252682 LenSx Laser System (8065000944)Alcon Laboratories, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −16 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −15 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −14 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −13 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −12 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −11 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −10 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −9 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −8 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −7 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| −6 | K120732 | Lenssx Laser System | Alcon Lensx, Inc. | 2012 | 1 |
| −5 | K123120 | Lensx Laser System | Alcon Lensx, Inc. | 2012 | — |
| −4 | K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016 | — |
| −3 | K163551 | LenSx Laser System | Alcon Laboratories, Inc. | 2017 | — |
| −2 | K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018 | — |
| −1 | K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | 2025 | — |
| 0 (this device) | K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 16.7 · 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 |
|---|---|---|---|
| * | K243896 | LenSx Laser System (8065998162)Summary page 6…ser System 3. PREDICATE DEVICE [per [807.92(a)(3)] Predicate Device LenSx Laser System (8065998162) 510(k) Number K243896 Regulation Number and 21 CFR 886.4390, Ophthalmic Laser (OOE) Name (Product Code in Parentheses)… | 2025 |
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 34 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 18 of the 95 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. 2025, 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 LenSx Laser system is indicated for use: * In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery. * In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery. * In the…
Read the full statement (108 words)
The LenSx Laser system is indicated for use:
* In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
* In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
* In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
* In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252682: LenSx Laser System (8065000944).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252682
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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