FDA 510(k)

Pentacam® Cornea OCT

K-Number: K251848 · 2026-03-13

Decision Date2026-03-13

Product CodeMXK

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Pentacam® Cornea OCT is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Optikgeräte GmbH. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K251848. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pentacam® Cornea OCT?

Pentacam® Cornea OCT is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Oculus Optikgeräte GmbH. The 510(k) number is K251848.

When did Pentacam® Cornea OCT receive FDA 510(k) clearance?

Pentacam® Cornea OCT received FDA 510(k) clearance on 2026-03-13, under 510(k) number K251848.

Who is the listed applicant for Pentacam® Cornea OCT?

The FDA 510(k) record lists Oculus Optikgeräte GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pentacam® Cornea OCT?

The FDA product code for Pentacam® Cornea OCT is MXK.

Other records listing Oculus Optikgeräte GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202989Myopia Master

Related Devices (Code: MXK)

K252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey Corporation K223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbH K201724Pentacam AXL WaveOculus Optikgerate GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.