FDA 510(k)

IPL Treatment Device (MDSQMC-01)

Número K: K243123 · 2025-07-03

RequerenteMedusa (Guangxi)Medical Devices Co., Ltd.

Data da decisão2025-07-03

Código do produtoONF

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

IPL Treatment Device (MDSQMC-01) is the device name listed in this FDA 510(k) record. The listed applicant is Medusa (Guangxi)Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K243123. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IPL Treatment Device (MDSQMC-01)?

IPL Treatment Device (MDSQMC-01) is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Medusa (Guangxi)Medical Devices Co., Ltd.. The 510(k) number is K243123.

When did IPL Treatment Device (MDSQMC-01) receive FDA 510(k) clearance?

IPL Treatment Device (MDSQMC-01) received FDA 510(k) clearance on 2025-07-03, under 510(k) number K243123.

Who is the listed applicant for IPL Treatment Device (MDSQMC-01)?

The FDA 510(k) record lists Medusa (Guangxi)Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Treatment Device (MDSQMC-01)?

The FDA product code for IPL Treatment Device (MDSQMC-01) is ONF.

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

Dispositivos Relacionados (Código: ONF)

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLC K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.K240314MULA (K2-A1)Guangzhou Ciellulu Photoelectric Technology 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.