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 Oct 19, 2011 as substantially equivalent to K102727 (Lensar, Inc., 2011) and 2 other predicates after an 89-day review. Its family tree reaches back 11 generations to 1991. 7 later devices descend from it.
- Decided
- Oct 19, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K913697 (1991). 73 ancestors in all, the oldest K844373 (1985). 7 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 7 generations between
- 3 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 2 generations backK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- 1 generation backK102727 Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
- This deviceK112098 TBDLensar, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK120214 TBDLensar, Inc. · 2012
- Descendant · 2 generations on · 5 of its ownK122829 Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK123859 TBDLensar, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK143010 LENSAR Laser System - fs 3DLensar, Inc. · 2015
- Descendant · 4 generations on · 2 of its ownK152453 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2015
Show all 11 generations
- Root · 11 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 10 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 9 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 8 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 7 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 6 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 5 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 4 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 3 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 2 generations backK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- 1 generation backK102727 Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
- This deviceK112098 TBDLensar, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120214TBDLensar, Inc. · 2012 · cites it directly6descendants
- K122829Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc. · 2012 · 2 generations on5descendants
- K123859TBDLensar, Inc. · 2013 · 2 generations on4descendants
- K143010LENSAR Laser System - fs 3DLensar, Inc. · 2015 · 3 generations on3descendants
- K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2015 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −10 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −9 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −8 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −7 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −6 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −5 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −4 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −3 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −2 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| −1 | K102727 | Lensar Laser System for Anterior Capsulotomy | Lensar, Inc. | 2011 | — |
| 0 (this device) | K112098 | TBD | Lensar, Inc. | 2011 | — |
| +1 | K120214 | TBD | Lensar, Inc. | 2012 | — |
| +2 | K122829 | Lensar Laser System - FS 3D for Corneal Incisions | Lensar, Inc. | 2012 | — |
| +2 | K123859 | TBD | Lensar, Inc. | 2013 | — |
| +3 | K143010 | LENSAR Laser System - fs 3D | Lensar, Inc. | 2015 | — |
| +4 | K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 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 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102727 | Lensar Laser System for Anterior CapsulotomySummary page 1…ny and laser phaco fragmentation performed individually or consecutively during the same surgery (K 102727). A new laser device with modification to the pulse width of the lase… | 2011 |
| * | K090633 | Lensar Laser SystemSummary page 1…ophthalmic surgical laser that has been cleared for use in anterior capsulotomy in cataract surgery (K090633) and anterior capsulotorny and laser phaco fragmentation performed… | 2010 |
| Kept off the family tree | K094052 | FDA’s K094052 is Lensx 550 Laser System. Model 550 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K082947 | Lensx 550 Laser SystemSummary page 2…tiorCa sulot omy KU94052 04/23/2010 Anterior Capsulotomy & Lens Fragmentation LenSx 550 Laser System - Laser Technology K082947 08/14/2009 and Indications for Use predicate device AnteriorCapsulotomy *The activit… | 2009 |
| Kept off the family tree | K089475 | LenSx 550 Laser System Model 550 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…CES 510(K) # TRADE NAME MANUFACTURER 1020672an LensAR Laser System LensAR, Inc. K089475 n LenSx 550 Laser System Model 550 LenSx Lasers, Inc. DEVICE DESCRIPTION The predicate LensAR Laser Syste… |
What descends from it? (7)
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 20 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 73 ancestors have a recall of any class.
- Of its descendants, K120214 (Lensar, Inc., 2012) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K102727.
How does its category compare?
All OOE devicesOOE Ophthalmic Femtosecond Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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-fs Laser System is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112098: TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112098
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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