FDA 510(k)

808nm半导体激光脱毛机

K号: K252048 · 2026-02-03

申请人Xi'An Taibo Electronic Technology Co., Ltd.

决定日期2026-02-03

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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半导体激光脱毛机

器械摘要

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