# K042810: Centurion Ses Epikeratome

- Pathway: 510(k) (Special)
- Applicant: Norwood Abbey, Ltd.
- Decided: Oct 28, 2004 after 16 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.
No later device cites it as a predicate yet.
0 of 5 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 1.

## Indications for use
The Norwood Abbey 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/K042810
Methodology: https://510kreport.com/methodology