FDA 510(k)

Myopia Master

K-Number: K202989 · 2021-07-14

Decision Date2021-07-14

Product CodeMXK

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Myopia Master is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Optikgeräte GmbH. It received FDA 510(k) clearance on 2021-07-14 under 510(k) 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. The listed applicant is Oculus Optikgeräte GmbH. The 510(k) number is K202989.

When did Myopia Master receive FDA 510(k) clearance?

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

Who is the listed applicant for Myopia Master?

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

What is the FDA product code for Myopia Master?

The FDA product code for Myopia Master is MXK.

Other records listing Oculus Optikgeräte 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.

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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.K201724Pentacam AXL WaveOculus Optikgerate 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.