FDA 510(k)

Nd: YAG Laser Therapy System (QN-1)

Número K: K250722 · 2025-06-06

Data da decisão2025-06-06

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nd: YAG Laser Therapy System (QN-1) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei JT Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K250722. 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 Nd: YAG Laser Therapy System (QN-1)?

Nd: YAG Laser Therapy System (QN-1) is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Hebei JT Medical Co., Ltd.. The 510(k) number is K250722.

When did Nd: YAG Laser Therapy System (QN-1) receive FDA 510(k) clearance?

Nd: YAG Laser Therapy System (QN-1) received FDA 510(k) clearance on 2025-06-06, under 510(k) number K250722.

Who is the listed applicant for Nd: YAG Laser Therapy System (QN-1)?

The FDA 510(k) record lists Hebei JT Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nd: YAG Laser Therapy System (QN-1)?

The FDA product code for Nd: YAG Laser Therapy System (QN-1) is GEX. This falls under the Gastroenterology category.

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