FDA 510(k)

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)

Número K: K250656 · 2025-04-04

RequerenteWuhan Pioon Technology Co., Ltd.

Data da decisão2025-04-04

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Pioon Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K250656. 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 (Models: MZ-GK, MZ-K20, MZ-N75)?

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K250656.

When did Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) receive FDA 510(k) clearance?

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K250656.

Who is the listed applicant for Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)?

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

What is the FDA product code for Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)?

The FDA product code for Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) is GEX. This falls under the Gastroenterology category.

Ensaios clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Wuhan Pioon Technology Co., Ltd. como candidato(a)

K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)K240747Medical Diode Laser (M2-GK)K240644Laser Diodo Médico (S1Pro)K240179Medical Diode Laser (Model: L2)K231548Medical Diode Laser, Model S1Pro

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.