FDA 510(k)

CO2 Laser Therapy Systems

Número K: K162398 · 2017-07-06

RequerenteBeijing Sincoheren Science and Technology Development Co.

Data da decisão2017-07-06

Código do produtoONG

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CO2 Laser Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sincoheren Science and Technology Development Co.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K162398. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CO2 Laser Therapy Systems?

CO2 Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Beijing Sincoheren Science and Technology Development Co.. The 510(k) number is K162398.

When did CO2 Laser Therapy Systems receive FDA 510(k) clearance?

CO2 Laser Therapy Systems received FDA 510(k) clearance on 2017-07-06, under 510(k) number K162398.

Who is the listed applicant for CO2 Laser Therapy Systems?

The FDA 510(k) record lists Beijing Sincoheren Science and Technology Development Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser Therapy Systems?

The FDA product code for CO2 Laser Therapy Systems is ONG.

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 Beijing Sincoheren Science and Technology Development Co. como candidato(a)

K163123Q-Switched Nd:YAG Laser Therapy Systems

Dispositivos Relacionados (Código: ONG)

K252155AVAVA™ Sistema de Tratamento de PeleAVAVA, Inc.K244060eCO2 3DLutronic Corporation K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ Sistema de Tratamento de PeleAVAVA, Inc.K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic K223871Miria Skin Treatment SystemAVAVA, Inc.

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.