510(k) · Cleared
ClearedVictus Femtosecond Laser Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technolas Perfect Vision GmbH · OOE Ophthalmic Femtosecond Laser
Cleared on Jul 15, 2014 as substantially equivalent to K122386 (Technolas Perfect Vision GmbH, 2013) and 5 other predicates after a 127-day review. Its family tree reaches back 15 generations to 1991. 3 later devices descend from it.
- Decided
- Jul 15, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K913697 (1991). 89 ancestors in all, the oldest K822112 (1982). 3 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 11 generations between
- 3 generations backK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
- 2 generations backK122386 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013
- 1 generation backK132534 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- This deviceK140615 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- Descendant · cites it directly · 2 of its ownK151161 VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2015
- Descendant · 2 generations on · 1 of its ownK171014 VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2017
- Descendant · 3 generations on · 0 of its ownK200724 VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2020
Show all 15 generations
- Root · 15 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 14 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 13 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 12 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 11 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 10 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 9 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 8 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 7 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 6 generations backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 5 generations backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- 4 generations backK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- 3 generations backK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
- 2 generations backK122386 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013
- 1 generation backK132534 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- This deviceK140615 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
Most influential descendants
Showing 3 of 3 · See all- K151161VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2015 · cites it directly2descendants
- K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2017 · 2 generations on1descendant
- K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −14 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −13 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −12 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −11 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −10 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −9 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −8 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −7 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −6 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −5 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| −4 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
| −3 | K120426 | Victus Laser Platform | Technolas Perfect Vision GmbH | 2012 | — |
| −2 | K122386 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2013 | — |
| −1 | K132534 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
| 0 (this device) | K140615 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
| +1 | K151161 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2015 | — |
| +2 | K171014 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2017 | — |
| +3 | K200724 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 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 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K122386 | Victus Femtosecond Laser PlatformSummary page 1…HQC (Unit, Lens fragmentation) Substantially Equivalent To: 510(k) Product Trade Name Current Manufacturer Number K122386, VICTUS Fermosecond Laser Technolas Perfect Vision GmbH K135234 Platform K094052, LenSx… | 2013 |
| * | K132534 | Victus Femtosecond Laser PlatformSummary page 2…ents undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (via K122386), and for corneal incisions (via K132534). This 5 10(k) expands the list of indications for use to include laser-assisted lens fragmentation during cataract surgery for n… | 2014 |
| * | K094052 | Lensx 550 Laser System. Model 550Summary page 1…Current Manufacturer Number K122386, VICTUS Fermosecond Laser Technolas Perfect Vision GmbH K135234 Platform K094052, LenSx Laser LenSx, an Alcon company K101626, K120732 ____________… | 2010 |
| * | K101626 | Lensx Laser SystemSummary page 1…cond Laser Technolas Perfect Vision GmbH K135234 Platform K094052, LenSx Laser LenSx, an Alcon company K101626, K120732 ____________ ______________ K 102727 LensAR Laser… | 2010 |
| * | K120732 | Lenssx Laser SystemSummary page 1…Technolas Perfect Vision GmbH K135234 Platform K094052, LenSx Laser LenSx, an Alcon company K101626, K120732 ____________ ______________ K 102727 LensAR Laser Lens… | 2012 |
| * | K102727 | Lensar Laser System for Anterior CapsulotomySummary page 1…2, LenSx Laser LenSx, an Alcon company K101626, K120732 ____________ ______________ K 102727 LensAR Laser LensAR Inc. Page I of 6 === Pag… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151161 | VICTUS Femtosecond Laser Platform | 2015 | 2 |
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 23 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 20 of the 89 ancestors have a recall of any class.
- Of its descendants, K151161 (Technolas Perfect Vision GmbH, 2015) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K122386.
How does its category compare?
All OOE devicesOOE Ophthalmic Femtosecond Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 VICTUS Femntosecond Laser Platform is indicated for use in:
* the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
* for anterior capsulotomy during cataract surgery
* the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.
* laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140615: Victus Femtosecond Laser Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140615
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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