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 a medical device manufactured by Oculus Optikgerate GmbH. It received FDA 510(k) clearance on 2016-01-20 under approval 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. It is manufactured by Oculus Optikgerate GmbH. The 510(k) number is K152311.
When was Pentacam AXL approved by the FDA?
Pentacam AXL received FDA 510(k) clearance on 2016-01-20, under approval number K152311.
What company makes Pentacam AXL?
Pentacam AXL is manufactured by Oculus Optikgerate GmbH.
What is the FDA product code for Pentacam AXL?
The FDA product code for Pentacam AXL 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.