FDA 510(k)

프로플렉스 CO2 레이저 파이버

K-번호: K203799 · 2021-09-20

결정일2021-09-20

제품 코드GEX

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

결정대체적으로 동일

기기 요약

ProFlex CO2 Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Innovaquartz, LLC. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K203799. 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 ProFlex CO2 Laser Fiber?

ProFlex CO2 Laser Fiber is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Innovaquartz, LLC. The 510(k) number is K203799.

When did ProFlex CO2 Laser Fiber receive FDA 510(k) clearance?

ProFlex CO2 Laser Fiber received FDA 510(k) clearance on 2021-09-20, under 510(k) number K203799.

Who is the listed applicant for ProFlex CO2 Laser Fiber?

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

What is the FDA product code for ProFlex CO2 Laser Fiber?

The FDA product code for ProFlex CO2 Laser Fiber is GEX. This falls under the Gastroenterology category.

Innovaquartz, LLC를 신청인으로 등재한 기타 기록

K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDD K180140프로플렉스 레이저 파이버

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