Pentacam AXL Wave
K-Number: K201724 · 2020-10-21
ApplicantOculus Optikgerate GmbH
Decision Date2020-10-21
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Pentacam AXL Wave is a medical device manufactured by Oculus Optikgerate GmbH. It received FDA 510(k) clearance on 2020-10-21 under approval 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. It is manufactured by Oculus Optikgerate GmbH. The 510(k) number is K201724.
When was Pentacam AXL Wave approved by the FDA?
Pentacam AXL Wave received FDA 510(k) clearance on 2020-10-21, under approval number K201724.
What company makes Pentacam AXL Wave?
Pentacam AXL Wave is manufactured by Oculus Optikgerate GmbH.
What is the FDA product code for Pentacam AXL Wave?
The FDA product code for Pentacam AXL Wave is MXK.
Other Devices by Oculus Optikgerate GmbH
Related Devices (Code: MXK)
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.