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FDA 510(k)

LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)

Número K: K251588 · 2025-08-21

RequerenteShenzhen Fittop Health Technology Co., Ltd.
Data da decisão2025-08-21
Código do produtoOHS
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Fittop Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K251588. 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 Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)?

LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Shenzhen Fittop Health Technology Co., Ltd.. The 510(k) number is K251588.

When did LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) receive FDA 510(k) clearance?

LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) received FDA 510(k) clearance on 2025-08-21, under 510(k) number K251588.

Who is the listed applicant for LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)?

The FDA 510(k) record lists Shenzhen Fittop Health 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 Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)?

The FDA product code for LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is OHS.

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Dispositivos Relacionados (Código: OHS)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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