510(k) · Cleared
Recalled · Class II · 2016Lenssx Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Lensx, Inc. · HQC Unit, Phacofragmentation
Cleared on Sep 6, 2012 as substantially equivalent to K101626 (Lensx Lasers, Inc., 2010) and 7 other predicates after a 181-day review. Its family tree reaches back 11 generations to 1991. 12 later devices descend from it. It has been recalled once.
- Decided
- Sep 6, 2012
- Review
- 181 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 8
Its longest line of descent runs back 11 generations to K913697 (1991). 64 ancestors in all, the oldest K822112 (1982). 12 later devices descend from it, 4 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 backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 1 generation backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- This deviceK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK132534 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- Descendant · cites it directly · 5 of its ownK123120 Lensx Laser SystemAlcon Lensx, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK161288 LenSX Laser SystemAlcon Laboratories, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK163551 LenSx Laser SystemAlcon Laboratories, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK141379 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 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 backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 1 generation backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- This deviceK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014 · cites it directly5descendants
- K123120Lensx Laser SystemAlcon Lensx, Inc. · 2012 · cites it directly5descendants
- K161288LenSX Laser SystemAlcon Laboratories, Inc. · 2016 · cites it directly4descendants
- K163551LenSx Laser SystemAlcon Laboratories, Inc. · 2017 · 2 generations on3descendants
- K141379Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2015 · 2 generations on3descendants
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 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −1 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| 0 (this device) | K120732 | Lenssx Laser System | Alcon Lensx, Inc. | 2012 | — |
| +1 | K132534 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
| +1 | K123120 | Lensx Laser System | Alcon Lensx, Inc. | 2012 | — |
| +1 | K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016 | — |
| +2 | K163551 | LenSx Laser System | Alcon Laboratories, Inc. | 2017 | — |
| +2 | K141379 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 HQC? 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 HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K101626 | Lensx Laser SystemSummary page 2…The LenSx Laser System proposed in this 5 10(k) premarket notification is a modification of the previously cleared LenSx Laser System, manufactured by Alcon LenSx, Inc. (K 10 1626). It is essentially the same laser system with the addition of a new indication for use, namely the creation of a corneal flap in… | 2010 |
| * | K993153 | Intralase 600C Laser KeratomeSummary page 1…Lasers, Inc. K10126 en~xLasr Sytem(now Alcon LenSx, Inc.) K993 153 K041 893 ItaaeLsrIntraLase Corp. K06037… | 1999 |
| * | K041893 | Intralase FS LaserSummary page 1…Lasers, Inc. K10126 en~xLasr Sytem(now Alcon LenSx, Inc.) K993 153 K041 893 ItaaeLsrIntraLase Corp. K060372… | 2005 |
| * | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Summary page 1…Alcon LenSx, Inc.) K993 153 K041 893 ItaaeLsrIntraLase Corp. K060372 nraaeLsr(now Abbot Medical Optics, Inc.) K073404… | 2006 |
| * | K073404 | Ifs Laser SystemSummary page 1…Corp. K060372 nraaeLsr(now Abbot Medical Optics, Inc.) K073404 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _… | 2008 |
| * | K101006 | Wavelight FS200 Laser System Model: FS200Summary page 1…ptics, Inc.) K073404 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ K101006 WaveLight FS 200 AcnRsacLd… | 2010 |
| * | K033354 | Femtec Laser MicrokeratomeSummary page 1…00 AcnRsacLd Laser System AcnRsacLd K033354 Femtec Laser Microkeratome 20/10 Perfect Vision… | 2004 |
| * | K100253 | Visumax Laser KeratomeSummary page 1…20/10 Perfect Vision __________________I__I OPtischeGerateGmbH K 100253 Visumax Laser Keratome Carl Zeiss Meditec DEVIC… | 2010 |
What descends from it? (12)
See all 124 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2016 | Class II | Z-1688-2016 | Software design (manufacturing process) | Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 11 of the 64 ancestors have a recall of any class.
- Of its descendants, K132534 (Technolas Perfect Vision GmbH, 2014) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K101626.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, 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 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The LenSx Laser System is indicated for use:
* In the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
* In the creation of a lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty.
* In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120732: Lenssx Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120732
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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