510(k) · Cleared
ClearedTBD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lensar, Inc. · OOE Ophthalmic Femtosecond Laser
Cleared on Mar 27, 2013 as substantially equivalent to K122829 (Lensar, Inc., 2012) and 2 other predicates after a 103-day review. Its family tree reaches back 14 generations to 1991. 4 later devices descend from it.
- Decided
- Mar 27, 2013
- Review
- 103 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K913697 (1991). 82 ancestors in all, the oldest K822112 (1982). 4 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 10 generations between
- 3 generations backK112098 TBDLensar, Inc. · 2011
- 2 generations backK120214 TBDLensar, Inc. · 2012
- 1 generation backK122829 Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc. · 2012
- This deviceK123859 TBDLensar, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK143010 LENSAR Laser System - fs 3DLensar, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK152453 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK170576 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK171337 LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc. · 2017
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 backK102727 Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
- 3 generations backK112098 TBDLensar, Inc. · 2011
- 2 generations backK120214 TBDLensar, Inc. · 2012
- 1 generation backK122829 Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc. · 2012
- This deviceK123859 TBDLensar, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K143010LENSAR Laser System - fs 3DLensar, Inc. · 2015 · cites it directly3descendants
- K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2015 · 2 generations on2descendants
- K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2017 · 2 generations on1descendant
- K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc. · 2017 · cites it directly0descendants
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 | K102727 | Lensar Laser System for Anterior Capsulotomy | Lensar, Inc. | 2011 | — |
| −3 | K112098 | TBD | Lensar, Inc. | 2011 | — |
| −2 | K120214 | TBD | Lensar, Inc. | 2012 | — |
| −1 | K122829 | Lensar Laser System - FS 3D for Corneal Incisions | Lensar, Inc. | 2012 | — |
| 0 (this device) | K123859 | TBD | Lensar, Inc. | 2013 | — |
| +1 | K143010 | LENSAR Laser System - fs 3D | Lensar, Inc. | 2015 | — |
| +2 | K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2015 | — |
| +2 | K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017 | — |
| +1 | K171337 | LENSAR Laser System – fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 8 | 0 |
| 1998 | 9 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K122829 | Lensar Laser System - FS 3D for Corneal IncisionsSummary page 1…lassification Code(s): 21 CFR 886.4390 OOE; 21 CER 886.4670 HQC PREDICATE DEVICES 510O(K) # TRADE NAME MANUFACTURER K 122829 LENSAR Laser System - f's 3D LENSAR, Inc. K 120214 LENSAR Laser System - fs 3D LENSAR,… | 2012 |
| * | K120214 | TBDSummary page 1…PREDICATE DEVICES 510O(K) # TRADE NAME MANUFACTURER K 122829 LENSAR Laser System - f's 3D LENSAR, Inc. K 120214 LENSAR Laser System - fs 3D LENSAR, Inc. K101626 LenSx 550 Laser System LenSx La… | 2012 |
| * | K101626 | Lensx Laser SystemSummary page 1…MANUFACTURER K 122829 LENSAR Laser System - f's 3D LENSAR, Inc. K 120214 LENSAR Laser System - fs 3D LENSAR, Inc. K101626 LenSx 550 Laser System LenSx Lasers, Inc. (Alcon) DEVICE DESCRIPTION The predicate LENSAR Laser Syst… | 2010 |
What descends from it? (4)
2 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)
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 22 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 82 ancestors have a recall of any class.
- Of its descendants, K143010 (Lensar, Inc., 2015) has gone furthest, with 3 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. 2013, 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 LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness 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/K123859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123859: TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123859
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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