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FDA 510(k)

Luminice

K-Number: K214100 · 2022-02-24

Decision Date2022-02-24
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Luminice is the device name listed in this FDA 510(k) record. The listed applicant is Premier North America, Inc.. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K214100. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Luminice?

Luminice is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Premier North America, Inc.. The 510(k) number is K214100.

When did Luminice receive FDA 510(k) clearance?

Luminice received FDA 510(k) clearance on 2022-02-24, under 510(k) number K214100.

Who is the listed applicant for Luminice?

The FDA 510(k) record lists Premier North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luminice?

The FDA product code for Luminice is NFO.

Other records listing Premier North America, Inc. 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.

Related Devices (Code: NFO)

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.

Official Source

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