# K020482: Keratome Blade 200200 & 600600

- Pathway: 510(k) (Traditional)
- Applicant: Micro Specialties, Inc.
- Decided: Dec 16, 2002 after 306 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The MICROspecialties, keratome blades are designed to produce a corneal flap when used with the following Moria microkeratomes: MICROspecialties 200200 Blade for use on Moria LSK Microkeratome MICROspecialties 600600 Blade for use on Mona CB Microkeratome

Source page: https://510kreport.com/device/K020482
Methodology: https://510kreport.com/methodology