FDA 510(k)

SurgiLight 1470 Diode Laser System (Model:Halo)

Número K: K251049 · 2025-07-02

RequerenteMicro-Energy Medical Technology Co., Ltd.

Data da decisão2025-07-02

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SurgiLight 1470 Diode Laser System (Model:Halo) is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Energy Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K251049. 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 SurgiLight 1470 Diode Laser System (Model:Halo)?

SurgiLight 1470 Diode Laser System (Model:Halo) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Micro-Energy Medical Technology Co., Ltd.. The 510(k) number is K251049.

When did SurgiLight 1470 Diode Laser System (Model:Halo) receive FDA 510(k) clearance?

SurgiLight 1470 Diode Laser System (Model:Halo) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K251049.

Who is the listed applicant for SurgiLight 1470 Diode Laser System (Model:Halo)?

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

What is the FDA product code for SurgiLight 1470 Diode Laser System (Model:Halo)?

The FDA product code for SurgiLight 1470 Diode Laser System (Model:Halo) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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