510(k) · Cleared
ClearedLENSAR Laser System – fs 3D (LLS-fs 3D)
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 Aug 10, 2017 as substantially equivalent to K170576 (Lensar, Inc., 2017) and 2 other predicates after a 94-day review. Its family tree reaches back 18 generations to 1991.
- Decided
- Aug 10, 2017
- Review
- 94 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K913697 (1991). 86 ancestors in all, the oldest K822112 (1982). No later device cites it as a predicate yet.
- Root · 18 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 14 generations between
- 3 generations backK143010 LENSAR Laser System - fs 3DLensar, Inc. · 2015
- 2 generations backK152453 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2015
- 1 generation backK170576 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2017
- This deviceK171337 LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc. · 2017
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 backK102727 Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
- 7 generations backK112098 TBDLensar, Inc. · 2011
- 6 generations backK120214 TBDLensar, Inc. · 2012
- 5 generations backK122829 Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc. · 2012
- 4 generations backK123859 TBDLensar, Inc. · 2013
- 3 generations backK143010 LENSAR Laser System - fs 3DLensar, Inc. · 2015
- 2 generations backK152453 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2015
- 1 generation backK170576 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2017
- This deviceK171337 LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc. · 2017
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 | K102727 | Lensar Laser System for Anterior Capsulotomy | Lensar, Inc. | 2011 | — |
| −7 | K112098 | TBD | Lensar, Inc. | 2011 | — |
| −6 | K120214 | TBD | Lensar, Inc. | 2012 | — |
| −5 | K122829 | Lensar Laser System - FS 3D for Corneal Incisions | Lensar, Inc. | 2012 | — |
| −4 | K123859 | TBD | Lensar, Inc. | 2013 | — |
| −3 | K143010 | LENSAR Laser System - fs 3D | Lensar, Inc. | 2015 | — |
| −2 | K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2015 | — |
| −1 | K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D)Summary page 4…ass: II 3.0 PREDICATE DEVICE(S) The legally marketed (predicate) devices to which LENSAR is claiming substantial equivalence are: 510(k) Number . Device Date Cleared K170576 (Primary) | LENSAR Laser System - fs 3D (LLS-fs 3D) (Iris Registration 05/05/2017 and i-Optics Cassini, Nidek OPD Scan, Pentacam®… | 2017 |
| * | K112098 | TBDSummary page 4…ry) | LENSAR Laser System - fs 3D (LLS-fs 3D) (Iris Registration 05/05/2017 and i-Optics Cassini, Nidek OPD Scan, Pentacam® HR and AXL, and Topcon Aladdin Topographers) K112098 LENSAR Laser System —fs 3D (LLS-fs 3D) (Intended for use 10/19/2011 ' in cataract surgery includes anterior capsulotomy and laser… | 2011 |
| * | K123859 | TBDSummary page 4…ract surgery includes anterior capsulotomy and laser phacofragmentation, each of which may be performed either individually or consecutively during the same procedure.) K123859 LENSAR Laser System - fs 3D (LLS-fs 3D) (Intended for use 03/27/2013 in cataract surgery includes anterior capsulotomy, laser : p… | 2013 |
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 26 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 86 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. 2017, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171337: LENSAR Laser System – fs 3D (LLS-fs 3D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171337
Report an extraction error
Are you the manufacturer?
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