# K043183: EPI-K

- Pathway: 510(k) (Traditional)
- Applicant: Moria SA
- Decided: Mar 25, 2005 after 128 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: 5 generations back to K960261 (1996). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040297: Oneuse- Plus Microkeratome, Moria SA (2004) Summary page 1.
- K032978: Modification to Ciba Vision Centurion Ses Spikeratome, Ciba Vision Corporation (2003) Summary page 1.
- K041206: Epitome System, Gebauer Medizintechnik GmbH (2004) Summary page 2.

## Most influential descendants
- K172994: EPI K Console (2017), 0 descendants of its own

## Indications for use
The Epi-K TM is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.

Source page: https://510kreport.com/device/K043183
Methodology: https://510kreport.com/methodology