# K030891: Surgistar Microkeratome Blade, Model NO. 2400-LSK

- Pathway: 510(k) (Traditional)
- Applicant: Surgistar, Inc.
- Decided: Jun 17, 2003 after 88 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: 4 generations back to K935342 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories), Plancon Instruments (1997) Summary page 1.
- K981741: Carriazo Barraquer Microkeratome, Moria, Inc. (1998) Summary page 3.
- K002191: Carriazo Barraquer II Microkeratome, Moria, Inc. (2000)

## Indications for use
The Surgistar 2420-M2 Microkeratome is indicated for use as a replacement blade in the Moria M2 Microkeratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea. The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea. The Surgistar 2410-CB Microkeratome is indicated for use as a replacement blade in the Moria Carriazo Barraquer Microkeratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K030891
Methodology: https://510kreport.com/methodology