FDA 510(k)

핸드피코 분할 레이저 핸드피스 테이프

K-번호: K242534 · 2024-12-20

결정일2024-12-20

제품 코드GEX

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

결정Substantially Equivalent

기기 요약

HandPICO Fractional Laser Handpiece Tip is the device name listed in this FDA 510(k) record. The listed applicant is Vydence Medical. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242534. 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 HandPICO Fractional Laser Handpiece Tip?

HandPICO Fractional Laser Handpiece Tip is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Vydence Medical. The 510(k) number is K242534.

When did HandPICO Fractional Laser Handpiece Tip receive FDA 510(k) clearance?

HandPICO Fractional Laser Handpiece Tip received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242534.

Who is the listed applicant for HandPICO Fractional Laser Handpiece Tip?

The FDA 510(k) record lists Vydence Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HandPICO Fractional Laser Handpiece Tip?

The FDA product code for HandPICO Fractional Laser Handpiece Tip is GEX. This falls under the Gastroenterology category.

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FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

핸드피코 분할 레이저 핸드피스 테이프

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GEX)

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