Diode Laser Hair Removal Device
K-Number: K221312 · 2022-06-29
Decision Date2022-06-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode Laser Hair Removal Device is a medical device manufactured by Guangzhou Chuang Zao Mei Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-29 under approval number K221312. 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 Diode Laser Hair Removal Device?
Diode Laser Hair Removal Device is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Guangzhou Chuang Zao Mei Technology Co., Ltd.. The 510(k) number is K221312.
When was Diode Laser Hair Removal Device approved by the FDA?
Diode Laser Hair Removal Device received FDA 510(k) clearance on 2022-06-29, under approval number K221312.
What company makes Diode Laser Hair Removal Device?
Diode Laser Hair Removal Device is manufactured by Guangzhou Chuang Zao Mei Technology Co., Ltd..
What is the FDA product code for Diode Laser Hair Removal Device?
The FDA product code for Diode Laser Hair Removal Device 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.