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FDA 510(k)

808nm semiconductor laser hair removal machine

K-Number: K252048 · 2026-02-03

ApplicantXi'An Taibo Electronic Technology Co., Ltd.
Decision Date2026-02-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

808nm semiconductor laser hair removal machine is a medical device manufactured by Xi'An Taibo Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-03 under approval 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.

Frequently Asked Questions

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. It is manufactured by Xi'An Taibo Electronic Technology Co., Ltd.. The 510(k) number is K252048.

When was 808nm semiconductor laser hair removal machine approved by the FDA?

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

What company makes 808nm semiconductor laser hair removal machine?

808nm semiconductor laser hair removal machine is manufactured by Xi'An Taibo Electronic Technology Co., Ltd..

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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Official Source

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