# K062465: Zyoptix XP Epi Separator System

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Sep 6, 2006 after 13 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913697 (1991). 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)
- K040204: Zyoptix XP Microkeratome, Bausch & Lomb, Inc. (2004) Summary page 1.

## Recalls of this device
- Jun 8, 2007 · Not classified · Z-1021-2007: Reports have been received of stromal incursions after use of the product.

## Indications for use
The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.

Source page: https://510kreport.com/device/K062465
Methodology: https://510kreport.com/methodology