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FDA 510(k)

Materialise Mimics Enlight

K-Number: K190874 · 2019-06-05

ApplicantMaterialise NV
Decision Date2019-06-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Materialise Mimics Enlight is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2019-06-05 under 510(k) number K190874. 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 Materialise Mimics Enlight?

Materialise Mimics Enlight is a medical device that received FDA 510(k) clearance on 2019-06-05. The listed applicant is Materialise NV. The 510(k) number is K190874.

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

Materialise Mimics Enlight received FDA 510(k) clearance on 2019-06-05, under 510(k) number K190874.

Who is the listed applicant for Materialise Mimics Enlight?

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 Materialise Mimics Enlight?

The FDA product code for Materialise Mimics Enlight 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)

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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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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