# K032978: Modification to Ciba Vision Centurion Ses Spikeratome

- Pathway: 510(k) (Special)
- Applicant: Ciba Vision Corporation
- Decided: Oct 20, 2003 after 26 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: 3 generations back to K960261 (1996). 3 ancestors in all.
5 later devices descend from it; 3 cite 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)
- K031735: Centurion Ses Epikeratome, Ciba Vision Corporation (2003) Summary page 1.

## Most influential descendants
- 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
- K042810: Centurion Ses Epikeratome (2004), 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 LASIK or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K032978
Methodology: https://510kreport.com/methodology