# K033457: M2 Compatible Microkeratome Blade

- Pathway: 510(k) (Traditional)
- Applicant: Micro Specialties, Inc.
- Decided: May 25, 2004 after 208 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: 1 generation back to K002191 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191

Source page: https://510kreport.com/device/K033457
Methodology: https://510kreport.com/methodology