# K022560: M2 Single Use Microkertome

- Pathway: 510(k) (Traditional)
- Applicant: Moria SA
- Decided: Sep 27, 2002 after 56 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: 1 generation back to K002191 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003594: Carriazo Barraquer Single Use Microkeratome, Moria, Inc. (2001) Summary page 2.
- K002191: Carriazo Barraquer II Microkeratome, Moria, Inc. (2000) Summary page 2.

## Indications for use
The M2 SINGLE USE microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K022560
Methodology: https://510kreport.com/methodology