ProSun sunlamp products, Luxura sunlamp products
K-Number: K181455 · 2018-09-10
ApplicantProsun International, LLC
Decision Date2018-09-10
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ProSun sunlamp products, Luxura sunlamp products is a medical device manufactured by Prosun International, LLC. It received FDA 510(k) clearance on 2018-09-10 under approval number K181455. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ProSun sunlamp products, Luxura sunlamp products?
ProSun sunlamp products, Luxura sunlamp products is a medical device that received FDA 510(k) clearance on 2018-09-10. It is manufactured by Prosun International, LLC. The 510(k) number is K181455.
When was ProSun sunlamp products, Luxura sunlamp products approved by the FDA?
ProSun sunlamp products, Luxura sunlamp products received FDA 510(k) clearance on 2018-09-10, under approval number K181455.
What company makes ProSun sunlamp products, Luxura sunlamp products?
ProSun sunlamp products, Luxura sunlamp products is manufactured by Prosun International, LLC.
What is the FDA product code for ProSun sunlamp products, Luxura sunlamp products?
The FDA product code for ProSun sunlamp products, Luxura sunlamp products is LEJ.
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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.