# K040297: Oneuse- Plus Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Moria SA
- Decided: Mar 31, 2004 after 51 days
- Product code: HMY (Keratome, Battery-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 K935342 (1994). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981742: One UP Disposable Keratome Head, Moria, Inc. (1998) Summary page 1.
- K002191: Carriazo Barraquer II Microkeratome, Moria, Inc. (2000) Summary page 1.

## Most influential descendants
- K043183: EPI-K (2005), 1 descendant of its own
- K172994: EPI K Console (2017), 0 descendants of its own

## Indications for use
The OneUse - Plus Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K040297
Methodology: https://510kreport.com/methodology