# K072102: Epivision SL System

- Pathway: 510(k) (Traditional)
- Applicant: Gebauer Medizintechnik GmbH
- Decided: Jan 16, 2009 after 535 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: 6 generations back to K913697 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041206: Epitome System, Gebauer Medizintechnik GmbH (2004) Summary page 1.
- K014000: Vistitome 20-10 Microkeratome, Biovision AG (2002) Summary page 1.
- K042083: Modification to Visitome 20-10 Microkeratome, Biovision AG (2004) Summary page 1.

## Indications for use
The EpiVision™ SL System is indicated for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea and for use in the making of a corneal flap in patients undergoing LASIK treatment.

Source page: https://510kreport.com/device/K072102
Methodology: https://510kreport.com/methodology