510(k) · Cleared
ClearedHorus Laser Keratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · GEX Powered Laser Surgical Instrument
Cleared on Dec 22, 2006 as substantially equivalent to K013941 (Intra Lase Corp., 2002) and 1 other predicate after a 136-day review. Its family tree reaches back 4 generations to 1991. 15 later devices descend from it.
- Decided
- Dec 22, 2006
- Review
- 136 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913697 (1991). 6 ancestors in all, the oldest K892058 (1989). 15 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 3 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 2 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 1 generation backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- This deviceK062314 Horus Laser KeratomeCarl Zeiss Meditec, AG · 2006
- Descendant · cites it directly · 14 of its ownK100253 Visumax Laser KeratomeCarl Zeiss Meditec, AG · 2010 · Recalled
- Descendant · 2 generations on · 12 of its ownK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK132534 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- Descendant · 3 generations on · 5 of its ownK123120 Lensx Laser SystemAlcon Lensx, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK161288 LenSX Laser SystemAlcon Laboratories, Inc. · 2016
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K100253Visumax Laser KeratomeCarl Zeiss Meditec, AG · 2010 · cites it directly14descendants
- K120732Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · 2 generations on12descendants
- K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014 · 3 generations on5descendants
- K123120Lensx Laser SystemAlcon Lensx, Inc. · 2012 · 3 generations on5descendants
- K161288LenSX Laser SystemAlcon Laboratories, Inc. · 2016 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −3 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −2 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −1 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| 0 (this device) | K062314 | Horus Laser Keratome | Carl Zeiss Meditec, AG | 2006 | — |
| +1 | K100253 | Visumax Laser Keratome | Carl Zeiss Meditec, AG | 2010 | 1 |
| +2 | K120732 | Lenssx Laser System | Alcon Lensx, Inc. | 2012 | 1 |
| +3 | K132534 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
| +3 | K123120 | Lensx Laser System | Alcon Lensx, Inc. | 2012 | — |
| +3 | K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K013941 | Pulsion FS Laser KeratomeSummary page 1…HNO (21 CFR 886.4370) Trade/Proprietary name: Horus PREDICATE DEVICE Company: IntraLase Corporation Device: IntraLase FS Laser (K013941) Company: Bausch & Lomb Surgical Device: Hansatome Microkeratome (KO 10260) S… | 2002 |
| * | K010260 | Hansatome Microkeratome | 2001 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100253 | Visumax Laser Keratome | 2010 | 14 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K100253 (Carl Zeiss Meditec, AG, 2010) has gone furthest, with 14 descendants of its own.
- 6 other devices also cite its predicate K013941.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Horus Laser Keratome 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062314: Horus Laser Keratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062314
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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