Luminice
K-Number: K214100 · 2022-02-24
ApplicantPremier North America, Inc.
Decision Date2022-02-24
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Luminice is a medical device manufactured by Premier North America, Inc.. It received FDA 510(k) clearance on 2022-02-24 under approval 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. It is manufactured by Premier North America, Inc.. The 510(k) number is K214100.
When was Luminice approved by the FDA?
Luminice received FDA 510(k) clearance on 2022-02-24, under approval number K214100.
What company makes Luminice?
Luminice is manufactured by Premier North America, Inc..
What is the FDA product code for Luminice?
The FDA product code for Luminice is NFO.
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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.