FDA 510(k)

Optixon 1-Day

Número K: K201013 · 2020-09-18

Data da decisão2020-09-18

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Optixon 1-Day is the device name listed in this FDA 510(k) record. The listed applicant is Optixon, Inc.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K201013. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Optixon 1-Day?

Optixon 1-Day is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Optixon, Inc.. The 510(k) number is K201013.

When did Optixon 1-Day receive FDA 510(k) clearance?

Optixon 1-Day received FDA 510(k) clearance on 2020-09-18, under 510(k) number K201013.

Who is the listed applicant for Optixon 1-Day?

The FDA 510(k) record lists Optixon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optixon 1-Day?

The FDA product code for Optixon 1-Day is LPL.

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: LPL)

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.