FDA 510(k)

다이어프램 풀스 트랜스퍼트 퍼퓨저

K-번호: K253100 · 2025-10-23

결정일2025-10-23

제품 코드GEX

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

결정대체적으로 동일

기기 요약

MultiPulse TFL 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 2025-10-23 under 510(k) number K253100. 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 MultiPulse TFL?

MultiPulse TFL is a medical device that received FDA 510(k) clearance on 2025-10-23. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K253100.

When did MultiPulse TFL receive FDA 510(k) clearance?

MultiPulse TFL received FDA 510(k) clearance on 2025-10-23, under 510(k) number K253100.

Who is the listed applicant for MultiPulse TFL?

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 MultiPulse TFL?

The FDA product code for MultiPulse TFL is GEX. This falls under the Gastroenterology category.

Asclepion Laser Technologies GmbH를 신청인으로 등재한 기타 기록

K261094YellowStar K240831다이어트 솔로 K241600디어마블트 K240816미디오스타 K231876다이어프램 푸즈 MultiPulse HoPLUS K213597다이어트 솔로

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