FDA 510(k)

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)

Número K: K241857 · 2024-10-11

RequerenteDongguan Boyuan Intelligent Technology Co.,Ltd

Data da decisão2024-10-11

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Boyuan Intelligent Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K241857. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)?

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Dongguan Boyuan Intelligent Technology Co.,Ltd. The 510(k) number is K241857.

When did LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) receive FDA 510(k) clearance?

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) received FDA 510(k) clearance on 2024-10-11, under 510(k) number K241857.

Who is the listed applicant for LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)?

The FDA 510(k) record lists Dongguan Boyuan Intelligent Technology 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 (KFB290, KFB291, KFB265, KFB293)?

The FDA product code for LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) is OHS.

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