Decision Date2018-06-22
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
UV Lamps for Sunlamp Products is the device name listed in this FDA 510(k) record. The listed applicant is Feilo Sylvania Germany GmbH. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K180581. 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 UV Lamps for Sunlamp Products?
UV Lamps for Sunlamp Products is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Feilo Sylvania Germany GmbH. The 510(k) number is K180581.
When did UV Lamps for Sunlamp Products receive FDA 510(k) clearance?
UV Lamps for Sunlamp Products received FDA 510(k) clearance on 2018-06-22, under 510(k) number K180581.
Who is the listed applicant for UV Lamps for Sunlamp Products?
The FDA 510(k) record lists Feilo Sylvania Germany GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UV Lamps for Sunlamp Products?
The FDA product code for UV Lamps for 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.