FDA 510(k)

LeafPure-Echo (LM-LPNdA)

Número K: K253219 · 2025-11-25

RequerenteShenzhen Leaflife Technology Co., Ltd.

Data da decisão2025-11-25

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LeafPure-Echo (LM-LPNdA) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K253219. 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 LeafPure-Echo (LM-LPNdA)?

LeafPure-Echo (LM-LPNdA) is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K253219.

When did LeafPure-Echo (LM-LPNdA) receive FDA 510(k) clearance?

LeafPure-Echo (LM-LPNdA) received FDA 510(k) clearance on 2025-11-25, under 510(k) number K253219.

Who is the listed applicant for LeafPure-Echo (LM-LPNdA)?

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

What is the FDA product code for LeafPure-Echo (LM-LPNdA)?

The FDA product code for LeafPure-Echo (LM-LPNdA) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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