FDA 510(k)

808nm semiconductor laser hair removal machine

K-번호: K252048 · 2026-02-03

신청자Xi'An Taibo Electronic Technology Co., Ltd.

결정일2026-02-03

제품 코드GEX

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

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기기 요약

808nm semiconductor laser hair removal machine is the device name listed in this FDA 510(k) record. The listed applicant is Xi'An Taibo Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-03 under 510(k) number K252048. 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 808nm semiconductor laser hair removal machine?

808nm semiconductor laser hair removal machine is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Xi'An Taibo Electronic Technology Co., Ltd.. The 510(k) number is K252048.

When did 808nm semiconductor laser hair removal machine receive FDA 510(k) clearance?

808nm semiconductor laser hair removal machine received FDA 510(k) clearance on 2026-02-03, under 510(k) number K252048.

Who is the listed applicant for 808nm semiconductor laser hair removal machine?

The FDA 510(k) record lists Xi'An Taibo Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 808nm semiconductor laser hair removal machine?

The FDA product code for 808nm semiconductor laser hair removal machine is GEX. This falls under the Gastroenterology category.

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808nm semiconductor laser hair removal machine

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GEX)

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