# K100253: Visumax  Laser Keratome

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Jul 8, 2010 after 161 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913697 (1991). 31 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062314: Horus Laser Keratome, Carl Zeiss Meditec, AG (2006) Summary page 1.
- K041893: Intralase FS Laser, Intra Lase Corp. (2005) Summary page 1.
- K993153: Intralase 600C Laser Keratome, Intra Lase Corp. (1999) Summary page 2.
- K001211: Modification to Intralase 600C Laser Keratome, Intra Lase Corp. (2000) Summary page 2.
- K002890: Intralase 600C Laser Keratome, Intra Lase Corp. (2001) Summary page 2.
- K013941: Pulsion FS Laser Keratome, Intra Lase Corp. (2002) Summary page 2.
- K031960: Intralase FS Laser, Intra Lase Corp. (2003) Summary page 2.
- K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3, Intra Lase Corp. (2006) Summary page 2.
- K063682: Intralase Fusion Laser, Intra Lase Corp. (2007) Summary page 2.
- K073404: Ifs Laser System, Intra Lase Corp. (2008) Summary page 2.

## Most influential descendants
- 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
- K163551: LenSx Laser System (2017), 3 descendants of its own

## Recalls of this device
- Feb 3, 2014 · Class II · Z-1153-2014: Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

## Indications for use
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.

Source page: https://510kreport.com/device/K100253
Methodology: https://510kreport.com/methodology