FDA 510(k)

다이오드 레이저 시스템 (나이트 유니버스; 프리딕터)

K-번호: K250206 · 2025-04-24

신청자Ivylaser (Beijing) Technology Co.,Ltd

결정일2025-04-24

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Diode laser system (Night Universe; Predator) is the device name listed in this FDA 510(k) record. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K250206. 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 Diode laser system (Night Universe; Predator)?

Diode laser system (Night Universe; Predator) is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K250206.

When did Diode laser system (Night Universe; Predator) receive FDA 510(k) clearance?

Diode laser system (Night Universe; Predator) received FDA 510(k) clearance on 2025-04-24, under 510(k) number K250206.

Who is the listed applicant for Diode laser system (Night Universe; Predator)?

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

What is the FDA product code for Diode laser system (Night Universe; Predator)?

The FDA product code for Diode laser system (Night Universe; Predator) is GEX. This falls under the Gastroenterology category.

Ivylaser (Beijing) Technology Co.,Ltd를 신청인으로 등재한 기타 기록

K240611IVYLASER 다이오드 레이저 털 제거 시스템 (IVY-HR-Alloy)K230025IVYLASER 핸드홀드 헤어 레이저 기기

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