510(k) · Cleared
ClearedLensx Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lensx Lasers, Inc. · OOE Ophthalmic Femtosecond Laser
Cleared on Oct 18, 2010 as substantially equivalent to K082947 (Lensx Lasers, Inc., 2009) and 6 other predicates after a 131-day review. Its family tree reaches back 10 generations to 1991. 30 later devices descend from it.
- Decided
- Oct 18, 2010
- Review
- 131 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K913697 (1991). 60 ancestors in all, the oldest K822112 (1982). 30 later devices descend from it, 7 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 backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- This deviceK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- Descendant · cites it directly · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- Descendant · cites it directly · 12 of its ownK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- Descendant · 2 generations on · 7 of its ownK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
- Descendant · cites it directly · 6 of its ownK122386 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013
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 backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- This deviceK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · cites it directly19descendants
- K120732Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · cites it directly12descendants
- K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · 2 generations on8descendants
- K120426Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012 · 2 generations on7descendants
- K122386Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013 · cites it directly6descendants
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 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| 0 (this device) | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| +1 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
| +1 | K120732 | Lenssx Laser System | Alcon Lensx, Inc. | 2012 | 1 |
| +2 | K141476 | Wavelight FS200 Laser System | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014 | — |
| +2 | K120426 | Victus Laser Platform | Technolas Perfect Vision GmbH | 2012 | — |
| +1 | K122386 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2013 | — |
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 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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? (7)
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 |
|---|---|---|---|
| * | K082947 | Lensx 550 Laser SystemSummary page 1…sification Name: d. Classification Code(s): LenSx Laser System LenSx Laser System Laser Instrument, Surgical, Powered 21 CFR 886.4390; 79 OOE 4.3 PREDICATE DEVICES K082947 LenSx 550 Laser System LenSx Lasers, Inc. K090452 LenSx 550 Laser System LenSx Lasers, Inc. K092647 LenSx 550 Laser System LenSx… | 2009 |
| * | K094052 | Lensx 550 Laser System. Model 550 Our OCR of the scanned summary read K090452, FDA’s number for Neoss Implant System 03.25 (Neoss, Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “LenSx 550 Laser System”. | 2010 |
| * | K092647 | Lensx 550 Laser SystemSummary page 1…nt, Surgical, Powered 21 CFR 886.4390; 79 OOE 4.3 PREDICATE DEVICES K082947 LenSx 550 Laser System LenSx Lasers, Inc. K090452 LenSx 550 Laser System LenSx Lasers, Inc. K092647 LenSx 550 Laser System LenSx Lasers, Inc. . IntralLase Corp. K041893 InteaLase B Laser (now Abbot Medical Optics, Inc.) K822112 S… | 2009 |
| * | K041893 | Intralase FS LaserSummary page 1…K082947 LenSx 550 Laser System LenSx Lasers, Inc. K090452 LenSx 550 Laser System LenSx Lasers, Inc. K092647 LenSx 550 Laser System LenSx Lasers, Inc. . IntralLase Corp. K041893 InteaLase B Laser (now Abbot Medical Optics, Inc.) K822112 Sharpoint Angiotech K853598 Ophthalmic Knife with Nivesirs. Hid Remova… | 2005 |
| * | K822112 | Ophthalmic KnifeSummary page 1…LenSx 550 Laser System LenSx Lasers, Inc. K092647 LenSx 550 Laser System LenSx Lasers, Inc. . IntralLase Corp. K041893 InteaLase B Laser (now Abbot Medical Optics, Inc.) K822112 Sharpoint Angiotech K853598 Ophthalmic Knife with Nivesirs. Hid Removable Depth Guide i Al K863725 Cataract Diamond Knife Medical… | 1982 |
| * | K853598 | Ophthalmic Knife W/Removale Depth GuideSummary page 1…Lasers, Inc. K092647 LenSx 550 Laser System LenSx Lasers, Inc. . IntralLase Corp. K041893 InteaLase B Laser (now Abbot Medical Optics, Inc.) K822112 Sharpoint Angiotech K853598 Ophthalmic Knife with Nivesirs. Hid Removable Depth Guide i Al K863725 Cataract Diamond Knife Medical Tyataiumy Development Corp.… | 1985 |
| * | K863725 | Cataract Diamond KnifeSummary page 1…lLase Corp. K041893 InteaLase B Laser (now Abbot Medical Optics, Inc.) K822112 Sharpoint Angiotech K853598 Ophthalmic Knife with Nivesirs. Hid Removable Depth Guide i Al K863725 Cataract Diamond Knife Medical Tyataiumy Development Corp. 510(K) PREMARKET NOTIFICATION LENSX® LASERS, INC. LENSX® LASER SYSTE… | 1986 |
What descends from it? (30)
See all 307 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 4 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 60 ancestors have a recall of any class.
- Of its descendants, K113151 (Abbott Medical Optics, Inc., 2012) has gone furthest, with 19 descendants of its own.
- 6 other devices also cite its predicate K082947.
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 LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of 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. The LenSx Laser is indicated for use in patients undergoing penetrating…
Read the full statement (104 words)
The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of 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.
The LenSx Laser is indicated for use in patients undergoing penetrating keratoplasty for full thickness corneal replacement and in patients undergoing lamellar keratoplasty for partial thickness comeal replacement. The intended use in penetrating and lamellar keratoplasty includes the creation of single plane and multi-plane arc and circular cuts/incisions in the cornea.
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/K101626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101626: Lensx 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/K101626
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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