Cleared Traditional

Pentacam? Cornea OCT

K251848 · Oculus Optikger?te GmbH · Ophthalmic
Mar 2026
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K251848 is an FDA 510(k) clearance for the Pentacam? Cornea OCT, a Device, Analysis, Anterior Segment (Class II — Special Controls, product code MXK), submitted by Oculus Optikger?te GmbH (Wetzlar, DE). The FDA issued a Cleared decision on March 13, 2026, 270 days after receiving the submission on June 16, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K251848 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2025
Decision Date March 13, 2026
Days to Decision 270 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MXK — Device, Analysis, Anterior Segment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850