510(k) · Cleared
Recalled · Class II · 2014Visumax Laser Keratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · HQF Laser, Ophthalmic
Cleared on Jul 8, 2010 as substantially equivalent to K062314 (Carl Zeiss Meditec, AG, 2006) and 9 other predicates after a 161-day review. Its family tree reaches back 8 generations to 1991. 14 later devices descend from it. It has been recalled once.
- Decided
- Jul 8, 2010
- Review
- 161 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 10
Its longest line of descent runs back 8 generations to K913697 (1991). 31 ancestors in all, the oldest K860001 (1986). 14 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 7 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 6 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 5 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 4 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 3 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 2 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 1 generation backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- This deviceK100253 Visumax Laser KeratomeCarl Zeiss Meditec, AG · 2010
- Descendant · cites it directly · 12 of its ownK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK132534 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- Descendant · 2 generations on · 5 of its ownK123120 Lensx Laser SystemAlcon Lensx, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK161288 LenSX Laser SystemAlcon Laboratories, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK163551 LenSx Laser SystemAlcon Laboratories, Inc. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K120732Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · cites it directly12descendants
- K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014 · 2 generations on5descendants
- K123120Lensx Laser SystemAlcon Lensx, Inc. · 2012 · 2 generations on5descendants
- K161288LenSX Laser SystemAlcon Laboratories, Inc. · 2016 · 2 generations on4descendants
- K163551LenSx Laser SystemAlcon Laboratories, Inc. · 2017 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −7 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −6 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −5 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −4 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −3 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −2 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −1 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| 0 (this device) | K100253 | Visumax Laser Keratome | Carl Zeiss Meditec, AG | 2010 | — |
| +1 | K120732 | Lenssx Laser System | Alcon Lensx, Inc. | 2012 | 1 |
| +2 | K132534 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
| +2 | K123120 | Lensx Laser System | Alcon Lensx, Inc. | 2012 | — |
| +2 | K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016 | — |
| +3 | K163551 | LenSx Laser System | Alcon Laboratories, Inc. | 2017 | — |
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 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K062314 | Horus Laser KeratomeSummary page 1…21 CFR 886.43 10; 79 HNO PREDICATE DEVICES FOR THE VISUMAx LASER KERATOME HORUS Laser Keratomne Carl Zeiss Meditec K0623 14 December 22, 2006 IntraLase FS Laser Abbott Medical Optics K04 1893 July 29, 2005 ==… | 2006 |
| * | K041893 | Intralase FS LaserSummary page 1…ATOME HORUS Laser Keratomne Carl Zeiss Meditec K0623 14 December 22, 2006 IntraLase FS Laser Abbott Medical Optics K04 1893 July 29, 2005 DEVICE DESCRIPTION The VisuMax Laser Keratome is an ophthalmic surgical femntosecond l… | 2005 |
| * | K993153 | Intralase 600C Laser KeratomeSummary page 2…by Abbott Medical Optics. The VisuMax Laser Keratome has the same operating characteristics as the predicate devices, the HORUS (5062314), and the IntraLase FS Lasers (K993 153, K00121 1, K002890, K013941, K03 1960, K041893, K060372, K063682, and K073404). Therefore, the VisuMax Laser Keratomne is substan… | 1999 |
| * | K001211 | Modification to Intralase 600C Laser KeratomeSummary page 2…Medical Optics. The VisuMax Laser Keratome has the same operating characteristics as the predicate devices, the HORUS (5062314), and the IntraLase FS Lasers (K993 153, K00121 1, K002890, K013941, K03 1960, K041893, K060372, K063682, and K073404). Therefore, the VisuMax Laser Keratomne is substantially equ… | 2000 |
| * | K002890 | Intralase 600C Laser KeratomeSummary page 2…ptics. The VisuMax Laser Keratome has the same operating characteristics as the predicate devices, the HORUS (5062314), and the IntraLase FS Lasers (K993 153, K00121 1, K002890, K013941, K03 1960, K041893, K060372, K063682, and K073404). Therefore, the VisuMax Laser Keratomne is substantially equivalent t… | 2001 |
| * | K013941 | Pulsion FS Laser KeratomeSummary page 2…he VisuMax Laser Keratome has the same operating characteristics as the predicate devices, the HORUS (5062314), and the IntraLase FS Lasers (K993 153, K00121 1, K002890, K013941, K03 1960, K041893, K060372, K063682, and K073404). Therefore, the VisuMax Laser Keratomne is substantially equivalent to these l… | 2002 |
| * | K031960 | Intralase FS LaserSummary page 2…x Laser Keratome has the same operating characteristics as the predicate devices, the HORUS (5062314), and the IntraLase FS Lasers (K993 153, K00121 1, K002890, K013941, K03 1960, K041893, K060372, K063682, and K073404). Therefore, the VisuMax Laser Keratomne is substantially equivalent to these legally mar… | 2003 |
| * | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Summary page 2…s the same operating characteristics as the predicate devices, the HORUS (5062314), and the IntraLase FS Lasers (K993 153, K00121 1, K002890, K013941, K03 1960, K041893, K060372, K063682, and K073404). Therefore, the VisuMax Laser Keratomne is substantially equivalent to these legally marketed predicate de… | 2006 |
| * | K063682 | Intralase Fusion LaserSummary page 2…e operating characteristics as the predicate devices, the HORUS (5062314), and the IntraLase FS Lasers (K993 153, K00121 1, K002890, K013941, K03 1960, K041893, K060372, K063682, and K073404). Therefore, the VisuMax Laser Keratomne is substantially equivalent to these legally marketed predicate devices. S… | 2007 |
| * | K073404 | Ifs Laser SystemSummary page 2…haracteristics as the predicate devices, the HORUS (5062314), and the IntraLase FS Lasers (K993 153, K00121 1, K002890, K013941, K03 1960, K041893, K060372, K063682, and K073404). Therefore, the VisuMax Laser Keratomne is substantially equivalent to these legally marketed predicate devices. SUMMARY OR PRO… | 2008 |
What descends from it? (14)
See all 142 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 |
|---|---|---|---|---|
| Feb 3, 2014 | Class II | Z-1153-2014 | Mixed-up of materials/components | Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. |
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 2.2 years on median.
- 6 of the 31 ancestors have a recall of any class.
- Of its descendants, K120732 (Alcon Lensx, Inc., 2012) has gone furthest, with 12 descendants of its own.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The VisuMax Laser Keratome is indicated for the following:
* In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
* In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
* In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty;
* In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100253 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100253: Visumax Laser Keratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100253
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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