# K032836: M3 Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Moria SA
- Decided: Jun 18, 2004 after 281 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: 2 generations back to K935342 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002191: Carriazo Barraquer II Microkeratome, Moria, Inc. (2000) Summary page 1.
- K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories), Plancon Instruments (1997) Summary page 1.
- K941550: Automatic Corneal Shaper Surgical Instrument, Chiron Vision Corp. (1994) Summary page 1.

## Indications for use
The M3 microkeratome is intended for use in the making of a comeal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K032836
Methodology: https://510kreport.com/methodology