FDA 510(k)

AcuPulse (이전에는 AcuPulse 30/40 ST라고 불렸음); AcuPulse 40W G; AcuPulse DUO

K-번호: K180597 · 2018-04-03

결정일2018-04-03

제품 코드GEX

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

결정대체적으로 동일

기기 요약

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K180597. 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 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO?

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Lumenis, Ltd.. The 510(k) number is K180597.

When did AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO receive FDA 510(k) clearance?

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO received FDA 510(k) clearance on 2018-04-03, under 510(k) number K180597.

Who is the listed applicant for AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO?

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

What is the FDA product code for AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO?

The FDA product code for AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO is GEX. This falls under the Gastroenterology category.