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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 the device name listed in this FDA 510(k) record. The listed applicant is Aesthetic Technology, Ltd.. It received FDA 510(k) clearance on 2024-06-04 under 510(k) 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. The listed applicant is Aesthetic Technology, Ltd.. The 510(k) number is K240222.

When did Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) receive FDA 510(k) clearance?

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

Who is the listed applicant for Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)?

The FDA 510(k) record lists Aesthetic Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Aesthetic Technology, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212275Dermalux Flex MDK202028dermalux Flex MDK200659Dermalux Tri-Wave MD

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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