# K172994: EPI K Console

- Pathway: 510(k) (Special)
- Applicant: Moria SA
- Decided: Oct 26, 2017 after 29 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: 6 generations back to K960261 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043183: EPI-K, Moria SA (2005) Summary page 4.

## Indications for use
The Epi-K 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/K172994
Methodology: https://510kreport.com/methodology