510(k) · Cleared
ClearedLensar Laser System for Anterior Capsulotomy
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 16, 2011 as substantially equivalent to K090633 (Lensar, Inc., 2010) and 4 other predicates after a 175-day review. Its family tree reaches back 10 generations to 1991. 12 later devices descend from it.
- Decided
- Mar 16, 2011
- Review
- 175 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K913697 (1991). 72 ancestors in all, the oldest K844373 (1985). 12 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 6 generations between
- 3 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 2 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 1 generation backK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- This deviceK102727 Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK112098 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
Show all 10 generations
- Root · 10 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 9 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 8 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 7 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 6 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 5 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 4 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 3 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 2 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 1 generation backK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- This deviceK102727 Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K112098TBDLensar, Inc. · 2011 · cites it directly7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −9 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −8 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −7 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −6 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −5 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −4 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −3 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −2 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −1 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| 0 (this device) | K102727 | Lensar Laser System for Anterior Capsulotomy | Lensar, Inc. | 2011 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2020 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090633 | Lensar Laser SystemSummary page 1…21 CER 886.4670 I-QC PREDICATE DEVICES 510O(K) #I TRADE NAME MANUFACTURER K090633 LensAR Laser System for Anterior Capsulotomy LensAR, Inc. K094052 and LenSx 550 Laser System Model 550… | 2010 |
| * | K094052 | Lensx 550 Laser System. Model 550Summary page 1…510O(K) #I TRADE NAME MANUFACTURER K090633 LensAR Laser System for Anterior Capsulotomy LensAR, Inc. K094052 and LenSx 550 Laser System Model 550 LenSx Lasers, Inc. K082947 K02 1566 and Infiniti Cataract… | 2010 |
| * | K082947 | Lensx 550 Laser SystemSummary page 1…33 LensAR Laser System for Anterior Capsulotomy LensAR, Inc. K094052 and LenSx 550 Laser System Model 550 LenSx Lasers, Inc. K082947 K02 1566 and Infiniti Cataract Extraction System Alcon Laboratories, Inc. K082845… | 2009 |
| * | K021566 | InfinitiSummary page 1…nsAR Laser System for Anterior Capsulotomy LensAR, Inc. K094052 and LenSx 550 Laser System Model 550 LenSx Lasers, Inc. K082947 K02 1566 and Infiniti Cataract Extraction System Alcon Laboratories, Inc. K082845… | 2002 |
| * | K082845 | Infiniti Vision System with Ozil IPSummary page 1…System Model 550 LenSx Lasers, Inc. K082947 K02 1566 and Infiniti Cataract Extraction System Alcon Laboratories, Inc. K082845 ___________ LensAR, Inc. - 51 0(k) K102727… | 2009 |
What descends from it? (12)
See all 123 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 1.6 years on median.
- 15 of the 72 ancestors have a recall of any class.
- Of its descendants, K112098 (Lensar, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K090633.
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 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/K102727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102727: Lensar Laser System for Anterior Capsulotomy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102727
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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