FDA 510(k)

LED光谱治疗仪器

K号: K231894 · 2023-09-20

申请人Shenzhenshi Sincoheren S&T Development Co., Ltd.

决定日期2023-09-20

产品代码GEX

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决定实质等同

器械摘要

LED Spectrum therapy instrument is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhenshi Sincoheren S&T Development Co., Ltd.. It received FDA 510(k) clearance on 2023-09-20 under 510(k) number K231894. 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 LED Spectrum therapy instrument?

LED Spectrum therapy instrument is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Shenzhenshi Sincoheren S&T Development Co., Ltd.. The 510(k) number is K231894.

When did LED Spectrum therapy instrument receive FDA 510(k) clearance?

LED Spectrum therapy instrument received FDA 510(k) clearance on 2023-09-20, under 510(k) number K231894.

Who is the listed applicant for LED Spectrum therapy instrument?

The FDA 510(k) record lists Shenzhenshi Sincoheren S&T Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Spectrum therapy instrument?

The FDA product code for LED Spectrum therapy instrument is GEX. This falls under the Gastroenterology category.

列明Shenzhenshi Sincoheren S&T Development Co., Ltd.为申报人的其他记录

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