DermRays Revive
K-Number: K231910 · 2024-01-30
ApplicantWuhan Lotuxs Technology Co., Ltd.
Decision Date2024-01-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DermRays Revive is a medical device manufactured by Wuhan Lotuxs Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-30 under approval number K231910. 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 DermRays Revive?
DermRays Revive is a medical device that received FDA 510(k) clearance on 2024-01-30. It is manufactured by Wuhan Lotuxs Technology Co., Ltd.. The 510(k) number is K231910.
When was DermRays Revive approved by the FDA?
DermRays Revive received FDA 510(k) clearance on 2024-01-30, under approval number K231910.
What company makes DermRays Revive?
DermRays Revive is manufactured by Wuhan Lotuxs Technology Co., Ltd..
What is the FDA product code for DermRays Revive?
The FDA product code for DermRays Revive 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.