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FDA 510(k)

LED Spectrum therapy instrument

K-Number: K231894 · 2023-09-20

ApplicantShenzhenshi Sincoheren S&T Development Co., Ltd.
Decision Date2023-09-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Shenzhenshi Sincoheren S&T Development Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231749Radio Frequency System

Related Devices (Code: GEX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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