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FDA 510(k)

Mimics Enlight CMF

K-Number: K223427 · 2024-05-31

ApplicantMaterialise NV
Decision Date2024-05-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mimics Enlight CMF is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K223427. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mimics Enlight CMF?

Mimics Enlight CMF is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Materialise NV. The 510(k) number is K223427.

When did Mimics Enlight CMF receive FDA 510(k) clearance?

Mimics Enlight CMF received FDA 510(k) clearance on 2024-05-31, under 510(k) number K223427.

Who is the listed applicant for Mimics Enlight CMF?

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

What is the FDA product code for Mimics Enlight CMF?

The FDA product code for Mimics Enlight CMF is LLZ.

Other records listing Materialise NV 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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Related Devices (Code: LLZ)

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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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