# K062314: Horus Laser Keratome

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Dec 22, 2006 after 136 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913697 (1991). 6 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013941: Pulsion FS Laser Keratome, Intra Lase Corp. (2002) Summary page 1.
- K010260: Hansatome Microkeratome, Bausch & Lomb, Inc. (2001)

## Most influential descendants
- K100253: Visumax  Laser Keratome (2010), 14 descendants of its own
- K120732: Lenssx Laser System (2012), 12 descendants of its own
- K132534: Victus Femtosecond Laser Platform (2014), 5 descendants of its own
- K123120: Lensx Laser System (2012), 5 descendants of its own
- K161288: LenSX Laser System (2016), 4 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K062314
Methodology: https://510kreport.com/methodology