FDA 510(k)

Q-Switched Nd:Yag 레이저

K-번호: K232716 · 2023-11-30

결정일2023-11-30

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Q-Switched Nd:Yag laser is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Zhemai Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K232716. 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 Q-Switched Nd:Yag laser?

Q-Switched Nd:Yag laser is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Hebei Zhemai Technology Co., Ltd.. The 510(k) number is K232716.

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

Q-Switched Nd:Yag laser received FDA 510(k) clearance on 2023-11-30, under 510(k) number K232716.

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

The FDA 510(k) record lists Hebei Zhemai Technology 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?

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

Hebei Zhemai Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K232708강한 파동 조명 치료 장치 K232709다이오드 레이저 치료 장치

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