FDA 510(k)

베네스 빠른 전류 레이저 시스템

K-번호: K162765 · 2017-01-11

결정일2017-01-11

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Venus Velocity Diode Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept , Ltd.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162765. 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 Venus Velocity Diode Laser System?

Venus Velocity Diode Laser System is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Venus Concept , Ltd.. The 510(k) number is K162765.

When did Venus Velocity Diode Laser System receive FDA 510(k) clearance?

Venus Velocity Diode Laser System received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162765.

Who is the listed applicant for Venus Velocity Diode Laser System?

The FDA 510(k) record lists Venus Concept , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venus Velocity Diode Laser System?

The FDA product code for Venus Velocity Diode Laser System is GEX. This falls under the Gastroenterology category.

Venus Concept , Ltd.를 신청인으로 등재한 기타 기록

K153717베네스 베르사 시스템 K152790베네스 베르사 시스템

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