FDA 510(k)

Q-Switched Nd:Yag laser (K690)

Número K: K252515 · 2025-11-06

RequerenteHebei Keylaser Sci-Tech Co.,Ltd

Data da decisão2025-11-06

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Q-Switched Nd:Yag laser (K690) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Keylaser Sci-Tech Co.,Ltd. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K252515. 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 (K690)?

Q-Switched Nd:Yag laser (K690) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Hebei Keylaser Sci-Tech Co.,Ltd. The 510(k) number is K252515.

When did Q-Switched Nd:Yag laser (K690) receive FDA 510(k) clearance?

Q-Switched Nd:Yag laser (K690) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K252515.

Who is the listed applicant for Q-Switched Nd:Yag laser (K690)?

The FDA 510(k) record lists Hebei Keylaser Sci-Tech 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 (K690)?

The FDA product code for Q-Switched Nd:Yag laser (K690) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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