FDA 510(k)

ERISE 레이저 핸드피스

K-번호: K202258 · 2021-04-26

결정일2021-04-26

제품 코드GEX

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

결정대체적으로 동일

기기 요약

ERISE Laser handpiece is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-04-26 under 510(k) number K202258. 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 ERISE Laser handpiece?

ERISE Laser handpiece is a medical device that received FDA 510(k) clearance on 2021-04-26. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K202258.

When did ERISE Laser handpiece receive FDA 510(k) clearance?

ERISE Laser handpiece received FDA 510(k) clearance on 2021-04-26, under 510(k) number K202258.

Who is the listed applicant for ERISE Laser handpiece?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERISE Laser handpiece?

The FDA product code for ERISE Laser handpiece is GEX. This falls under the Gastroenterology category.

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