FDA 510(k)

ND:YAG 레이저

K-번호: K193464 · 2020-04-13

신청자Beijing Superlaser Technology Co., Ltd.

결정일2020-04-13

제품 코드GEX

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

결정대체적으로 동일

기기 요약

ND:YAG Laser is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Superlaser Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-04-13 under 510(k) number K193464. 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?

ND:YAG Laser is a medical device that received FDA 510(k) clearance on 2020-04-13. The listed applicant is Beijing Superlaser Technology Co., Ltd.. The 510(k) number is K193464.

When did ND:YAG Laser receive FDA 510(k) clearance?

ND:YAG Laser received FDA 510(k) clearance on 2020-04-13, under 510(k) number K193464.

Who is the listed applicant for ND:YAG Laser?

The FDA 510(k) record lists Beijing Superlaser Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ND:YAG Laser?

The FDA product code for ND:YAG Laser is GEX. This falls under the Gastroenterology category.

Beijing Superlaser Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K251457다이오드 레이저 치료 장치 (VADER)K200042CO2 레이저 시스템 K192516다이오드 레이저 808nm K192519다중 모드 워크스테이션

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