FDA 510(k)

피부과 디오드 레이저 시스템

K-번호: K212478 · 2022-01-14

신청자Beijing Stelle Laser Technology Co., Ltd.

결정일2022-01-14

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Dermatological diode laser system is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Stelle Laser Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K212478. 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 Dermatological diode laser system?

Dermatological diode laser system is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Beijing Stelle Laser Technology Co., Ltd.. The 510(k) number is K212478.

When did Dermatological diode laser system receive FDA 510(k) clearance?

Dermatological diode laser system received FDA 510(k) clearance on 2022-01-14, under 510(k) number K212478.

Who is the listed applicant for Dermatological diode laser system?

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

What is the FDA product code for Dermatological diode laser system?

The FDA product code for Dermatological diode laser system is GEX. This falls under the Gastroenterology category.

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

피부과 디오드 레이저 시스템

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GEX)

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