Epildream HP 4000 MED
K-Number: K222352 · 2023-04-27
ApplicantD.E.A Project S.R.1.
Decision Date2023-04-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Epildream HP 4000 MED is a medical device manufactured by D.E.A Project S.R.1.. It received FDA 510(k) clearance on 2023-04-27 under approval number K222352. 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 Epildream HP 4000 MED?
Epildream HP 4000 MED is a medical device that received FDA 510(k) clearance on 2023-04-27. It is manufactured by D.E.A Project S.R.1.. The 510(k) number is K222352.
When was Epildream HP 4000 MED approved by the FDA?
Epildream HP 4000 MED received FDA 510(k) clearance on 2023-04-27, under approval number K222352.
What company makes Epildream HP 4000 MED?
Epildream HP 4000 MED is manufactured by D.E.A Project S.R.1..
What is the FDA product code for Epildream HP 4000 MED?
The FDA product code for Epildream HP 4000 MED 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.