Medical Picosecond ND: YAG Laser System (PZ-6)
K-Number: K250041 · 2025-05-14
Decision Date2025-05-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Medical Picosecond ND: YAG Laser System (PZ-6) is a medical device manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-14 under approval number K250041. 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 Medical Picosecond ND: YAG Laser System (PZ-6)?
Medical Picosecond ND: YAG Laser System (PZ-6) is a medical device that received FDA 510(k) clearance on 2025-05-14. It is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K250041.
When was Medical Picosecond ND: YAG Laser System (PZ-6) approved by the FDA?
Medical Picosecond ND: YAG Laser System (PZ-6) received FDA 510(k) clearance on 2025-05-14, under approval number K250041.
What company makes Medical Picosecond ND: YAG Laser System (PZ-6)?
Medical Picosecond ND: YAG Laser System (PZ-6) is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd..
What is the FDA product code for Medical Picosecond ND: YAG Laser System (PZ-6)?
The FDA product code for Medical Picosecond ND: YAG Laser System (PZ-6) is GEX. This falls under the Gastroenterology category.
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Official Source
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