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FDA 510(k)

Myopia Master

K-Number: K202989 · 2021-07-14

ApplicantOculus Optikgeräte GmbH
Decision Date2021-07-14
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Myopia Master is a medical device manufactured by Oculus Optikgeräte GmbH. It received FDA 510(k) clearance on 2021-07-14 under approval number K202989. 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 Myopia Master?

Myopia Master is a medical device that received FDA 510(k) clearance on 2021-07-14. It is manufactured by Oculus Optikgeräte GmbH. The 510(k) number is K202989.

When was Myopia Master approved by the FDA?

Myopia Master received FDA 510(k) clearance on 2021-07-14, under approval number K202989.

What company makes Myopia Master?

Myopia Master is manufactured by Oculus Optikgeräte GmbH.

What is the FDA product code for Myopia Master?

The FDA product code for Myopia Master is MXK.

Other Devices by Oculus Optikgeräte GmbH

K251848Pentacam® Cornea OCT

Related Devices (Code: MXK)

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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.

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