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FDA 510(k)

Q-Switched Nd:YAG Laser (SHE-LSP101-1)

K-Number: K250936 · 2025-06-12

ApplicantBeijing Sano Laser S&T Development Co.,Ltd
Decision Date2025-06-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Q-Switched Nd:YAG Laser (SHE-LSP101-1) is a medical device manufactured by Beijing Sano Laser S&T Development Co.,Ltd. It received FDA 510(k) clearance on 2025-06-12 under approval number K250936. 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 Q-Switched Nd:YAG Laser (SHE-LSP101-1)?

Q-Switched Nd:YAG Laser (SHE-LSP101-1) is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K250936.

When was Q-Switched Nd:YAG Laser (SHE-LSP101-1) approved by the FDA?

Q-Switched Nd:YAG Laser (SHE-LSP101-1) received FDA 510(k) clearance on 2025-06-12, under approval number K250936.

What company makes Q-Switched Nd:YAG Laser (SHE-LSP101-1)?

Q-Switched Nd:YAG Laser (SHE-LSP101-1) is manufactured by Beijing Sano Laser S&T Development Co.,Ltd.

What is the FDA product code for Q-Switched Nd:YAG Laser (SHE-LSP101-1)?

The FDA product code for Q-Switched Nd:YAG Laser (SHE-LSP101-1) is GEX. This falls under the Gastroenterology category.

Other Devices by Beijing Sano Laser S&T Development Co.,Ltd

K191970Diode Laser Hair Removal System K230024HI-EMT MAGSHAPE K233416Cryojet Plus (SHE-ACP001-1) K242941CO2 Laser Therapy Systems (SHE-LSP003-1)

Related Devices (Code: GEX)

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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.

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