# K113066: Corvis ST

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Optikgerate GmbH
- Decided: Nov 8, 2012 after 388 days
- Product code: HKX (Tonometer, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1930
- 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 K902798 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913189: Nidek Model NT-1000, Nidek, Inc. (1991) Summary page 1.
- K041841: Pachycam, Oculus Optikgerate GmbH (2005) Summary page 1.

## Indications for use
The Corvis ST is intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism. In addition, the Corvis ST is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea.

Source page: https://510kreport.com/device/K113066
Methodology: https://510kreport.com/methodology