FDA 510(k)

Smart Photon Micro-current Device, Model: EP-300

Número K: K162652 · 2017-10-25

RequerenteLi-Tek Electronic Technology Corporation

Data da decisão2017-10-25

Código do produtoNFO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart Photon Micro-current Device, Model: EP-300 is the device name listed in this FDA 510(k) record. The listed applicant is Li-Tek Electronic Technology Corporation. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K162652. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Smart Photon Micro-current Device, Model: EP-300?

Smart Photon Micro-current Device, Model: EP-300 is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Li-Tek Electronic Technology Corporation. The 510(k) number is K162652.

When did Smart Photon Micro-current Device, Model: EP-300 receive FDA 510(k) clearance?

Smart Photon Micro-current Device, Model: EP-300 received FDA 510(k) clearance on 2017-10-25, under 510(k) number K162652.

Who is the listed applicant for Smart Photon Micro-current Device, Model: EP-300?

The FDA 510(k) record lists Li-Tek Electronic Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Photon Micro-current Device, Model: EP-300?

The FDA product code for Smart Photon Micro-current Device, Model: EP-300 is NFO.

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 Li-Tek Electronic Technology Corporation como candidato(a)

K162106Micro-current Wrinkle Reduction Facial service, model EP-400 K162098LED Phototherapy Device

Dispositivos Relacionados (Código: NFO)

K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.K262861PureLift Pro MaxXtreem Pulse, LLC K260387SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)Hironic Co., Ltd.K253932FACEGYM Pro Device (HD-109)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260179VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical 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.