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 Feb 8, 2013 as substantially equivalent to K120426 (Technolas Perfect Vision GmbH, 2012) and 3 other predicates after a 186-day review. Its family tree reaches back 13 generations to 1991. 6 later devices descend from it.
- Decided
- Feb 8, 2013
- Review
- 186 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K913697 (1991). 66 ancestors in all, the oldest K822112 (1982). 6 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 9 generations between
- 3 generations backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- 2 generations backK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- 1 generation backK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
- This deviceK122386 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013
- Descendant · cites it directly · 5 of its ownK132534 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- Descendant · 2 generations on · 3 of its ownK141379 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2015
- Descendant · cites it directly · 3 of its ownK140615 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- Descendant · 2 generations on · 2 of its ownK151161 VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2015
- Descendant · 3 generations on · 1 of its ownK171014 VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2017
Show all 13 generations
- Root · 13 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 12 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 11 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 10 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 9 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 8 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 7 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 6 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 5 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 4 generations backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 3 generations backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- 2 generations backK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- 1 generation backK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
- This deviceK122386 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014 · cites it directly5descendants
- K141379Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2015 · 2 generations on3descendants
- K140615Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014 · cites it directly3descendants
- K151161VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2015 · 2 generations on2descendants
- K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −12 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −11 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −10 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −9 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −8 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −7 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −6 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −5 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −4 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −3 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| −2 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
| −1 | K120426 | Victus Laser Platform | Technolas Perfect Vision GmbH | 2012 | — |
| 0 (this device) | K122386 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2013 | — |
| +1 | K132534 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
| +2 | K141379 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2015 | — |
| +1 | K140615 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
| +2 | K151161 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2015 | — |
| +3 | K171014 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2017 | — |
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 | 4 | 0 |
| 2005 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K120426 | Victus Laser PlatformSummary page 1…HQF (Laser, Ophthalmic) Substantially Equivalent To: 510(k) Number Product Trade Name Current Manufacturer K 120426 VICTUS Femosecond Laser Technolas Perfect Vision Platform KI 10427 F… | 2012 |
| * | K110427 | Femtec Laser System for Capsulotomy | 2011 |
| * | K113151 | Ifs Laser SystemSummary page 4…to the technological characteristics of the VICTUS Femntosecond Laser Platform (K(120426), the Femtec Laser System for Anterior Capsulotomy (KI 10427), iFS Laser System (K 11315 1), the LenSx Laser (K(10 1626). The proposed additional indication for use of arcuate cuts / incisions for the VICTUS Femtosecond… | 2012 |
| * | K101626 | Lensx Laser SystemSummary page 1…nolas Perfect Vision Capsulotomy GmbH KI 13151 iFS Laser System Abbott Medical Optics K10 1626 LenSx Laser LenSx. an Alcon company 510(k) Summary… | 2010 |
What descends from it? (6)
2 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 22 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 66 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.
- 1 other device also cites its predicate K120426.
How does its category compare?
All OOE devicesOOE Ophthalmic Femtosecond Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 lamnellar resection of the cornea
* for anterior capsulotomy during cataract surgery
* the creation of penetrating arcuate cuts / incisions in the cornea in patients undergoing
cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts/
incisions in the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122386: 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/K122386
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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