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FDA 510(k)

Medical Diode Laser Hair Removal System (MNLT-D1)

Número K: K250431 · 2025-05-12

RequerenteShandong Moonlight Electronics Tech Co., Ltd.
Data da decisão2025-05-12
Código do produtoGEX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Diode Laser Hair Removal System (MNLT-D1) is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Moonlight Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K250431. 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 Medical Diode Laser Hair Removal System (MNLT-D1)?

Medical Diode Laser Hair Removal System (MNLT-D1) is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is Shandong Moonlight Electronics Tech Co., Ltd.. The 510(k) number is K250431.

When did Medical Diode Laser Hair Removal System (MNLT-D1) receive FDA 510(k) clearance?

Medical Diode Laser Hair Removal System (MNLT-D1) received FDA 510(k) clearance on 2025-05-12, under 510(k) number K250431.

Who is the listed applicant for Medical Diode Laser Hair Removal System (MNLT-D1)?

The FDA 510(k) record lists Shandong Moonlight Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Diode Laser Hair Removal System (MNLT-D1)?

The FDA product code for Medical Diode Laser Hair Removal System (MNLT-D1) is GEX. This falls under the Gastroenterology category.

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