FDA 510(k)

Dermatological Diode Laser Systems

K-Number: K210663 · 2021-04-26

ApplicantBeijing HuaCheng Taike Technology Co., Ltd.

Decision Date2021-04-26

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Dermatological Diode Laser Systems is a medical device manufactured by Beijing HuaCheng Taike Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-04-26 under approval number K210663. 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 Dermatological Diode Laser Systems?

Dermatological Diode Laser Systems is a medical device that received FDA 510(k) clearance on 2021-04-26. It is manufactured by Beijing HuaCheng Taike Technology Co., Ltd.. The 510(k) number is K210663.

When was Dermatological Diode Laser Systems approved by the FDA?

Dermatological Diode Laser Systems received FDA 510(k) clearance on 2021-04-26, under approval number K210663.

What company makes Dermatological Diode Laser Systems?

Dermatological Diode Laser Systems is manufactured by Beijing HuaCheng Taike Technology Co., Ltd..

What is the FDA product code for Dermatological Diode Laser Systems?

The FDA product code for Dermatological Diode Laser Systems is GEX. This falls under the Gastroenterology category.

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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.