FDA 510(k)

칸델라 Vbeam 패밀리 파동색광레이저 (Vbeam Prima, Vbeam Perfecta)

K-번호: K230990 · 2023-06-01

결정일2023-06-01

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corporation. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K230990. 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 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)?

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Candela Corporation. The 510(k) number is K230990.

When did Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) receive FDA 510(k) clearance?

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) received FDA 510(k) clearance on 2023-06-01, under 510(k) number K230990.

Who is the listed applicant for Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)?

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

What is the FDA product code for Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)?

The FDA product code for Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is GEX. This falls under the Gastroenterology category.