# K043150: Amadeus II Epikeratome

- Pathway: 510(k) (Special)
- Applicant: Sis Ltd., Surgical Instrument Systems
- Decided: Jan 31, 2005 after 77 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 K913697 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993190: Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis), Surgical Instrument Systems (Sis), Ltd. (2000) Summary page 2.

## Indications for use
The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

Source page: https://510kreport.com/device/K043150
Methodology: https://510kreport.com/methodology