# K040204: Zyoptix XP Microkeratome

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Mar 22, 2004 after 53 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913697 (1991). 4 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021640: Hansatome Excellus Microkeratome, Bausch & Lomb, Inc. (2002) Summary page 1.

## Most influential descendants
- K120426: Victus Laser Platform (2012), 7 descendants of its own
- K122386: Victus Femtosecond Laser Platform (2013), 6 descendants of its own
- K132534: Victus Femtosecond Laser Platform (2014), 5 descendants of its own
- K141379: Victus Femtosecond Laser Platform (2015), 3 descendants of its own
- K140615: Victus Femtosecond Laser Platform (2014), 3 descendants of its own

## Recalls of this device
- Apr 23, 2008 · Not classified · Z-0103-2009: The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
- Apr 23, 2008 · Not classified · Z-0104-2009: The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
- Jun 8, 2007 · Not classified · Z-1021-2007: Reports have been received of stromal incursions after use of the product.
- Jun 8, 2007 · Not classified · Z-1022-2007: Reports have been received of stromal incursions after use of the product.

## Indications for use
The ZyoptixTM XP Microkeratome is a precision-manufactured instrument indicated for use in creating a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K040204
Methodology: https://510kreport.com/methodology