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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Aesthetic Technology, Ltd.. It received FDA 510(k) clearance on 2020-05-09 under 510(k) 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. The listed applicant is Aesthetic Technology, Ltd.. The 510(k) number is K200659.

When did Dermalux Tri-Wave MD receive FDA 510(k) clearance?

Dermalux Tri-Wave MD received FDA 510(k) clearance on 2020-05-09, under 510(k) number K200659.

Who is the listed applicant for Dermalux Tri-Wave MD?

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?

The FDA product code for Dermalux Tri-Wave MD 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.

K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)K212275Dermalux Flex MDK202028dermalux Flex 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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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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