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FDA 510(k)

Pentacam AXL

K-Number: K152311 · 2016-01-20

ApplicantOculus Optikgerate GmbH
Decision Date2016-01-20
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Pentacam AXL is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Optikgerate GmbH. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152311. 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 AXL?

Pentacam AXL is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Oculus Optikgerate GmbH. The 510(k) number is K152311.

When did Pentacam AXL receive FDA 510(k) clearance?

Pentacam AXL received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152311.

Who is the listed applicant for Pentacam AXL?

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

What is the FDA product code for Pentacam AXL?

The FDA product code for Pentacam AXL is MXK.

Related Clinical Trials

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.

NCT07500272Agreement of Ocular Biometry and Intraocular Lens Power Between OA-2000 and Pentacam AXL in Cataract PatientsCOMPLETED

Other records listing Oculus Optikgerate 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.

K201724Pentacam AXL Wave

Related Devices (Code: MXK)

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.

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbHK252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey CorporationK223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte 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.

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