# K042083: Modification to Visitome 20-10 Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Biovision AG
- Decided: Nov 16, 2004 after 105 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: 5 generations back to K913697 (1991). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014000: Vistitome 20-10 Microkeratome, Biovision AG (2002) Summary page 2.
- K031960: Intralase FS Laser, Intra Lase Corp. (2003) Summary page 2.

## Most influential descendants
- K072102: Epivision SL System (2009), 0 descendants of its own

## Indications for use
The VISITOME 20-10 MICROKERATOME is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K042083
Methodology: https://510kreport.com/methodology