# K251848: Pentacam® Cornea OCT

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Optikgeräte GmbH
- Decided: Mar 13, 2026 after 270 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K012727 (2002). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222166: SOLIX, Optovue, Inc. (2022) Summary page 5.

## Indications for use
The Pentacam® Cornea OCT is a multifunction ophthalmic imaging device designed to acquire images of the anterior segment using Scheimpflug imaging (digital CMOS camera with slit-lamp illumination) and OCT. Scheimpflug imaging provides anterior segment visualization and quantitative anterior segment measurements. The OCT component of the system uses broadband Multi-SLD and is intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of corneal epithelium. The Penatcam® Cornea OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the anterior segment of the eye.

Source page: https://510kreport.com/device/K251848
Methodology: https://510kreport.com/methodology