FDA 510(k)

Q-Switched Nd: YAG Laser System (Glamor Q)

Número K: K260153 · 2026-04-20

RequerenteNanjing Bestview Laser S&T Co., Ltd.

Data da decisão2026-04-20

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Q-Switched Nd: YAG Laser System (Glamor Q) 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 2026-04-20 under 510(k) number K260153. 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 Q-Switched Nd: YAG Laser System (Glamor Q)?

Q-Switched Nd: YAG Laser System (Glamor Q) is a medical device that received FDA 510(k) clearance on 2026-04-20. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K260153.

When did Q-Switched Nd: YAG Laser System (Glamor Q) receive FDA 510(k) clearance?

Q-Switched Nd: YAG Laser System (Glamor Q) received FDA 510(k) clearance on 2026-04-20, under 510(k) number K260153.

Who is the listed applicant for Q-Switched Nd: YAG Laser System (Glamor Q)?

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 Q-Switched Nd: YAG Laser System (Glamor Q)?

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

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Fonte oficial

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