510(k) · Cleared
ClearedLensar Laser System
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 May 13, 2010 as substantially equivalent to K892058 (Intelligent Surgical Lasers, Inc., 1989) and 2 other predicates after a 430-day review. Its family tree reaches back 9 generations to 1991. 18 later devices descend from it.
- Decided
- May 13, 2010
- Review
- 430 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K913697 (1991). 49 ancestors in all, the oldest K860001 (1986). 18 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 5 generations between
- 3 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 2 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 1 generation backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- This deviceK090633 Lensar Laser SystemLensar, Inc. · 2010
- Descendant · cites it directly · 12 of its ownK102727 Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK110427 Femtec Laser System for CapsulotomyTechnolas Perfect Vision GmbH · 2011
- Descendant · 2 generations on · 7 of its ownK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
- Descendant · cites it directly · 7 of its ownK112098 TBDLensar, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK122386 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013
Show all 9 generations
- Root · 9 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 8 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 7 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 6 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 5 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 4 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 3 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 2 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 1 generation backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- This deviceK090633 Lensar Laser SystemLensar, Inc. · 2010
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011 · cites it directly12descendants
- K110427Femtec Laser System for CapsulotomyTechnolas Perfect Vision GmbH · 2011 · cites it directly8descendants
- K120426Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012 · 2 generations on7descendants
- K112098TBDLensar, Inc. · 2011 · cites it directly7descendants
- K122386Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −8 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −7 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −6 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −5 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −4 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −3 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −2 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −1 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| 0 (this device) | K090633 | Lensar Laser System | Lensar, Inc. | 2010 | — |
| +1 | K102727 | Lensar Laser System for Anterior Capsulotomy | Lensar, Inc. | 2011 | — |
| +1 | K110427 | Femtec Laser System for Capsulotomy | Technolas Perfect Vision GmbH | 2011 | — |
| +2 | K120426 | Victus Laser Platform | Technolas Perfect Vision GmbH | 2012 | — |
| +1 | K112098 | TBD | Lensar, Inc. | 2011 | — |
| +2 | K122386 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 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 16.8 · 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 |
|---|---|---|---|
| * | K892058 | ISL QC 2000Summary page 2…oduct Code(s): NCR, LXS, OOE LensAR, Inc. — 510(k) K090633 Summary of Safety and Effectiveness PREDICATE DEVICES: 510(K) Number TRADE NAME MANUFACTURER K892058 ISL QC 2000 Intelligent Surgical Lasers K001498 The Fugo Blade Medisurg Research and Management Corp. LenSx Lasers, Inc. K08294… | 1989 |
| * | K001498 | The Fugo BladeSummary page 2…(k) K090633 Summary of Safety and Effectiveness PREDICATE DEVICES: 510(K) Number TRADE NAME MANUFACTURER K892058 ISL QC 2000 Intelligent Surgical Lasers K001498 The Fugo Blade Medisurg Research and Management Corp. LenSx Lasers, Inc. K082947 LenSx 33 Journey, Suite 175 Aliso Viejo, CA 92… | 2000 |
| * | K082947 | Lensx 550 Laser System Cleared while this submission was under review Summary page 2…510(K) Number TRADE NAME MANUFACTURER K892058 ISL QC 2000 Intelligent Surgical Lasers K001498 The Fugo Blade Medisurg Research and Management Corp. LenSx Lasers, Inc. K082947 LenSx 33 Journey, Suite 175 Aliso Viejo, CA 92656 And by LenSx reference the following devices: K033354 FEMTEC Laser 20/10 Perf… | 2009 |
| † | K033354 | Femtec Laser Microkeratome | 2004 |
| † | K993153 | Intralase 600C Laser Keratome | 1999 |
| † | K001211 | Modification to Intralase 600C Laser Keratome | 2000 |
| † | K002890 | Intralase 600C Laser Keratome | 2001 |
| † | K013941 | Pulsion FS Laser Keratome | 2002 |
| † | K031960 | Intralase FS Laser | 2003 |
| † | K041893 | Intralase FS Laser | 2005 |
| † | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | 2006 |
| † | K063682 | Intralase Fusion Laser | 2007 |
| † | K073404 | Ifs Laser System | 2008 |
What descends from it? (18)
See all 184 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 19 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 49 ancestors have a recall of any class.
- Of its descendants, K102727 (Lensar, Inc., 2011) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K892058.
How does its category compare?
All OOE devicesOOE Ophthalmic Femtosecond Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 in cataract surgery.
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/K090633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090633: Lensar Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090633
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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