LUNE PureHygiene
K-Number: K234085 · 2024-03-25
ApplicantEnamel Pure
Decision Date2024-03-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LUNE PureHygiene is a medical device manufactured by Enamel Pure. It received FDA 510(k) clearance on 2024-03-25 under approval number K234085. 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 LUNE PureHygiene?
LUNE PureHygiene is a medical device that received FDA 510(k) clearance on 2024-03-25. It is manufactured by Enamel Pure. The 510(k) number is K234085.
When was LUNE PureHygiene approved by the FDA?
LUNE PureHygiene received FDA 510(k) clearance on 2024-03-25, under approval number K234085.
What company makes LUNE PureHygiene?
LUNE PureHygiene is manufactured by Enamel Pure.
What is the FDA product code for LUNE PureHygiene?
The FDA product code for LUNE PureHygiene 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.