FDA 510(k)

Thulium Laser System (Deluxlase)

Número K: K251919 · 2025-09-26

RequerenteNanjing Bestview Laser S&T Co., Ltd.

Data da decisão2025-09-26

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Thulium Laser System (Deluxlase) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K251919. 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.

Perguntas frequentes

What is the Thulium Laser System (Deluxlase)?

Thulium Laser System (Deluxlase) is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K251919.

When did Thulium Laser System (Deluxlase) receive FDA 510(k) clearance?

Thulium Laser System (Deluxlase) received FDA 510(k) clearance on 2025-09-26, under 510(k) number K251919.

Who is the listed applicant for Thulium Laser System (Deluxlase)?

The FDA 510(k) record lists Nanjing Bestview Laser S&T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thulium Laser System (Deluxlase)?

The FDA product code for Thulium Laser System (Deluxlase) is GEX. This falls under the Gastroenterology category.

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