Diode Laser Hair Removal System
K-Number: K191970 · 2020-04-06
Decision Date2020-04-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode Laser Hair Removal System is a medical device manufactured by Beijing Sano Laser S&T Development Co.,Ltd. It received FDA 510(k) clearance on 2020-04-06 under approval number K191970. 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 System?
Diode Laser Hair Removal System is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K191970.
When was Diode Laser Hair Removal System approved by the FDA?
Diode Laser Hair Removal System received FDA 510(k) clearance on 2020-04-06, under approval number K191970.
What company makes Diode Laser Hair Removal System?
Diode Laser Hair Removal System is manufactured by Beijing Sano Laser S&T Development Co.,Ltd.
What is the FDA product code for Diode Laser Hair Removal System?
The FDA product code for Diode Laser Hair Removal System 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.