# K041206: Epitome System

- Pathway: 510(k) (Traditional)
- Applicant: Gebauer Medizintechnik GmbH
- Decided: Sep 15, 2004 after 131 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- 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 K960261 (1996). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032978: Modification to Ciba Vision Centurion Ses Spikeratome, Ciba Vision Corporation (2003) Summary page 2.

## Most influential descendants
- K043183: EPI-K (2005), 1 descendant of its own
- K172994: EPI K Console (2017), 0 descendants of its own
- K072102: Epivision SL System (2009), 0 descendants of its own

## Indications for use
The epiTome System is indicated for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

Source page: https://510kreport.com/device/K041206
Methodology: https://510kreport.com/methodology