FDA 510(k)

Nd: YAG 레이저 치료 시스템 (QN-1)

K-번호: K250722 · 2025-06-06

결정일2025-06-06

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Hebei JT Medical Co., Ltd.를 신청인으로 등재한 기타 기록

K2406581060nm 레이저 본드 슬림 마신 K232181체형 조정 기계 (모델: CS2, CS3, CS5, CS7, CS8, CS11, CS13)

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