FDA 510(k)

네이: YAG 레이저 테라피 시스템

K-번호: K193477 · 2020-06-24

신청자Beijing Kes Biology Technology Co., Ltd.

결정일2020-06-24

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Nd: YAG Laser Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Kes Biology Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-24 under 510(k) number K193477. 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 Systems?

Nd: YAG Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2020-06-24. The listed applicant is Beijing Kes Biology Technology Co., Ltd.. The 510(k) number is K193477.

When did Nd: YAG Laser Therapy Systems receive FDA 510(k) clearance?

Nd: YAG Laser Therapy Systems received FDA 510(k) clearance on 2020-06-24, under 510(k) number K193477.

Who is the listed applicant for Nd: YAG Laser Therapy Systems?

The FDA 510(k) record lists Beijing Kes Biology 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 Therapy Systems?

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

Beijing Kes Biology Technology Co., Ltd.를 신청인으로 등재한 기타 기록

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