Primelase Excellence
K-Number: K191321 · 2019-08-02
ApplicantHigh Technology Products S.L.U
Decision Date2019-08-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Primelase Excellence is a medical device manufactured by High Technology Products S.L.U. It received FDA 510(k) clearance on 2019-08-02 under approval number K191321. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Primelase Excellence?
Primelase Excellence is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by High Technology Products S.L.U. The 510(k) number is K191321.
When was Primelase Excellence approved by the FDA?
Primelase Excellence received FDA 510(k) clearance on 2019-08-02, under approval number K191321.
What company makes Primelase Excellence?
Primelase Excellence is manufactured by High Technology Products S.L.U.
What is the FDA product code for Primelase Excellence?
The FDA product code for Primelase Excellence is GEX. This falls under the Gastroenterology category.
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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.