Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pentacam® Cornea OCT

K-Number: K251848 · 2026-03-13

ApplicantOculus Optikgeräte GmbH
Decision Date2026-03-13
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Pentacam® Cornea OCT is a medical device manufactured by Oculus Optikgeräte GmbH. It received FDA 510(k) clearance on 2026-03-13 under approval 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. It is manufactured by Oculus Optikgeräte GmbH. The 510(k) number is K251848.

When was Pentacam® Cornea OCT approved by the FDA?

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

What company makes Pentacam® Cornea OCT?

Pentacam® Cornea OCT is manufactured by Oculus Optikgeräte GmbH.

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

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

Other Devices by Oculus Optikgeräte GmbH

K202989Myopia Master

Related Devices (Code: MXK)

K152311Pentacam AXLOculus Optikgerate GmbH K182659Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems K191051ARGOSSantec Corporation K201724Pentacam AXL WaveOculus Optikgerate GmbH K202989Myopia MasterOculus Optikgeräte GmbH K211868MYAHVisia Imaging S.R.L.

Official Source

View on FDA Database →

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

↑