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FDA 510(k)

Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)

K-Number: K240222 · 2024-06-04

ApplicantAesthetic Technology, Ltd.
Decision Date2024-06-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) is a medical device manufactured by Aesthetic Technology, Ltd.. It received FDA 510(k) clearance on 2024-06-04 under approval number K240222. 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 MKII (1000021); Dermalux Compact MD (1000024)?

Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) is a medical device that received FDA 510(k) clearance on 2024-06-04. It is manufactured by Aesthetic Technology, Ltd.. The 510(k) number is K240222.

When was Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) approved by the FDA?

Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) received FDA 510(k) clearance on 2024-06-04, under approval number K240222.

What company makes Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)?

Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) is manufactured by Aesthetic Technology, Ltd..

What is the FDA product code for Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)?

The FDA product code for Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) is GEX. This falls under the Gastroenterology category.

Other Devices by Aesthetic Technology, Ltd.

K202028dermalux Flex MD K200659Dermalux Tri-Wave MD K212275Dermalux Flex MD

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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.

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