510(k) K251848

Pentacam® Cornea OCT by Oculus Optikgeräte GmbH — Product Code MXK

K251848 is an FDA 510(k) premarket notification submitted by Oculus Optikgeräte GmbH for the device "Pentacam® Cornea OCT". The FDA issued a decision of Substantially Equivalent on March 13, 2026. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Oculus Optikgeräte GmbH has at least 1 other 510(k) clearance on record.