# K031735: Centurion Ses Epikeratome

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Aug 21, 2003 after 78 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: 2 generations back to K960261 (1996). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960261: Pallikaris Brush, Alcon Laboratories, Inc. (1996) Summary page 2.
- K962989: Amoils Epithelial Scrubber, S. Percy Amoils (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K010400: Vacuum Assisted Core Biopsy Device, Promex, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K032978: Modification to Ciba Vision Centurion Ses Spikeratome (2003), 5 descendants of its own
- K041206: Epitome System (2004), 3 descendants of its own
- 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 ClBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASlK or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K031735
Methodology: https://510kreport.com/methodology