FDA 510(k)

LED Light Therapy Device, KN-7000L

Número K: K222751 · 2023-02-01

RequerenteXuzhou Kernel Medical Equipment Co., Ltd.

Data da decisão2023-02-01

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LED Light Therapy Device, KN-7000L is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K222751. 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.

Perguntas frequentes

What is the LED Light Therapy Device, KN-7000L?

LED Light Therapy Device, KN-7000L is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K222751.

When did LED Light Therapy Device, KN-7000L receive FDA 510(k) clearance?

LED Light Therapy Device, KN-7000L received FDA 510(k) clearance on 2023-02-01, under 510(k) number K222751.

Who is the listed applicant for LED Light Therapy Device, KN-7000L?

The FDA 510(k) record lists Xuzhou Kernel Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Device, KN-7000L?

The FDA product code for LED Light Therapy Device, KN-7000L is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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