FDA 510(k)

분할 CO2 레이저 치료 시스템 (FG900-S); 분할 CO2 레이저 치료 시스템 (FG900-S2)

K-번호: K241670 · 2024-12-20

결정일2024-12-20

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K241670. 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 Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)?

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Beijing Adss Development Co., Ltd.. The 510(k) number is K241670.

When did Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) receive FDA 510(k) clearance?

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K241670.

Who is the listed applicant for Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)?

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

What is the FDA product code for Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)?

The FDA product code for Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) is GEX. This falls under the Gastroenterology category.

Beijing Adss Development Co., Ltd.를 신청인으로 등재한 기타 기록

K233307강도 패턴 조명 치료 시스템 K231896다이오드 레이저 치료 시스템 K231318전자기 자극 장치(모델 EM Contouring과 Tesla Duet)K220268피코초 레이저 시스템 (모델 PS10-A 및 PS10-B)K192295PDT-페이스 K161926ND YAG Q-switch 레이저 치료 기기

10개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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