FDA 510(k)

피코초 Nd:YAG 레이저 시스템

K-번호: K240118 · 2024-04-30

신청자Smedtrum Medical Technology Co., Ltd.

결정일2024-04-30

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Picosecond Nd:YAG Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Smedtrum Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-30 under 510(k) number K240118. 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 Picosecond Nd:YAG Laser System?

Picosecond Nd:YAG Laser System is a medical device that received FDA 510(k) clearance on 2024-04-30. The listed applicant is Smedtrum Medical Technology Co., Ltd.. The 510(k) number is K240118.

When did Picosecond Nd:YAG Laser System receive FDA 510(k) clearance?

Picosecond Nd:YAG Laser System received FDA 510(k) clearance on 2024-04-30, under 510(k) number K240118.

Who is the listed applicant for Picosecond Nd:YAG Laser System?

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

What is the FDA product code for Picosecond Nd:YAG Laser System?

The FDA product code for Picosecond Nd:YAG Laser System is GEX. This falls under the Gastroenterology category.

Smedtrum Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K240482강한 파동 조명 시스템 (ST-690)K231394강한 파동 조명 시스템 K230580다이오드 레이저 시스템 K221597CO2 레이저 시스템

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.