Dermalux Tri-Wave MD
K-Number: K200659 · 2020-05-09
ApplicantAesthetic Technology, Ltd.
Decision Date2020-05-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dermalux Tri-Wave MD is a medical device manufactured by Aesthetic Technology, Ltd.. It received FDA 510(k) clearance on 2020-05-09 under approval number K200659. 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 Dermalux Tri-Wave MD?
Dermalux Tri-Wave MD is a medical device that received FDA 510(k) clearance on 2020-05-09. It is manufactured by Aesthetic Technology, Ltd.. The 510(k) number is K200659.
When was Dermalux Tri-Wave MD approved by the FDA?
Dermalux Tri-Wave MD received FDA 510(k) clearance on 2020-05-09, under approval number K200659.
What company makes Dermalux Tri-Wave MD?
Dermalux Tri-Wave MD is manufactured by Aesthetic Technology, Ltd..
What is the FDA product code for Dermalux Tri-Wave MD?
The FDA product code for Dermalux Tri-Wave MD 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.