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FDA 510(k)

LUCION

K-Number: K050033 · 2005-02-11

ApplicantMevisys Co., Ltd.
Decision Date2005-02-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUCION is the device name listed in this FDA 510(k) record. The listed applicant is Mevisys Co., Ltd.. It received FDA 510(k) clearance on 2005-02-11 under 510(k) number K050033. 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 LUCION?

LUCION is a medical device that received FDA 510(k) clearance on 2005-02-11. The listed applicant is Mevisys Co., Ltd.. The 510(k) number is K050033.

When did LUCION receive FDA 510(k) clearance?

LUCION received FDA 510(k) clearance on 2005-02-11, under 510(k) number K050033.

Who is the listed applicant for LUCION?

The FDA 510(k) record lists Mevisys Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUCION?

The FDA product code for LUCION is LLZ.

Related Clinical Trials

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Other records listing Mevisys Co., Ltd. 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.

K022692VOXELPLUS PACS

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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.

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