FDA 510(k)

MCL 31 디어마블트 시스템

K-번호: K210634 · 2022-04-13

결정일2022-04-13

제품 코드GEX

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

결정대체적으로 동일

기기 요약

MCL 31 Dermablate System is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K210634. 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 MCL 31 Dermablate System?

MCL 31 Dermablate System is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K210634.

When did MCL 31 Dermablate System receive FDA 510(k) clearance?

MCL 31 Dermablate System received FDA 510(k) clearance on 2022-04-13, under 510(k) number K210634.

Who is the listed applicant for MCL 31 Dermablate System?

The FDA 510(k) record lists Asclepion Laser Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCL 31 Dermablate System?

The FDA product code for MCL 31 Dermablate System is GEX. This falls under the Gastroenterology category.

Asclepion Laser Technologies GmbH를 신청인으로 등재한 기타 기록

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