Diode laser hair removal device
K-Number: K180353 · 2018-04-17
Decision Date2018-04-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode laser hair removal device is a medical device manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-04-17 under approval number K180353. 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 2018-04-17. It is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K180353.
When was Diode laser hair removal device approved by the FDA?
Diode laser hair removal device received FDA 510(k) clearance on 2018-04-17, under approval number K180353.
What company makes Diode laser hair removal device?
Diode laser hair removal device is manufactured by Zhengzhou PZ Laser Slim 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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Other Devices by Zhengzhou PZ Laser Slim Technology Co., Ltd.
K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
K250782Fractional CO2 Laser Machine
K250038Muscle Stimulator Device (PZ-100)
K250041Medical Picosecond ND: YAG Laser System (PZ-6)
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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.