FDA 510(k)

GLAM LED Facial Mask (TB-2386F)

Número K: K251727 · 2025-08-29

RequerenteTouchbeauty Beauty & Health (Shenzhen) Co., Ltd.

Data da decisão2025-08-29

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

GLAM LED Facial Mask (TB-2386F) is the device name listed in this FDA 510(k) record. The listed applicant is Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251727. 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 GLAM LED Facial Mask (TB-2386F)?

GLAM LED Facial Mask (TB-2386F) is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. The 510(k) number is K251727.

When did GLAM LED Facial Mask (TB-2386F) receive FDA 510(k) clearance?

GLAM LED Facial Mask (TB-2386F) received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251727.

Who is the listed applicant for GLAM LED Facial Mask (TB-2386F)?

The FDA 510(k) record lists Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLAM LED Facial Mask (TB-2386F)?

The FDA product code for GLAM LED Facial Mask (TB-2386F) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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