FDA 510(k)

Pentacam AXL Wave

K-Number: K201724 · 2020-10-21

Decision Date2020-10-21

Product CodeMXK

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Pentacam AXL Wave 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 2020-10-21 under 510(k) number K201724. 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 Wave?

Pentacam AXL Wave is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Oculus Optikgerate GmbH. The 510(k) number is K201724.

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

Pentacam AXL Wave received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201724.

Who is the listed applicant for Pentacam AXL Wave?

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 Wave?

The FDA product code for Pentacam AXL Wave is MXK.

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.

K152311Pentacam AXL

Related Devices (Code: MXK)

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH 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

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.