FDA 510(k)

의료 디오드 레이저 시스템

K-번호: K211977 · 2021-10-26

신청자Wuhan Dimed Laser Technology Co., Ltd.

결정일2021-10-26

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Medical Diode Laser Systems is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Dimed Laser Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-26 under 510(k) number K211977. 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 Medical Diode Laser Systems?

Medical Diode Laser Systems is a medical device that received FDA 510(k) clearance on 2021-10-26. The listed applicant is Wuhan Dimed Laser Technology Co., Ltd.. The 510(k) number is K211977.

When did Medical Diode Laser Systems receive FDA 510(k) clearance?

Medical Diode Laser Systems received FDA 510(k) clearance on 2021-10-26, under 510(k) number K211977.

Who is the listed applicant for Medical Diode Laser Systems?

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

What is the FDA product code for Medical Diode Laser Systems?

The FDA product code for Medical Diode Laser Systems is GEX. This falls under the Gastroenterology category.

Wuhan Dimed Laser Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K252063의료 디오드 레이저 시스템 (BERYLAS-12N); 의료 디오드 레이저 시스템 (BERYLAS-15N); 의료 디오드 레이저 시스템 (HARLAS-45JN); 의료 디오드 레이저 시스템 (HARLAS-46JN)

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