FDA 510(k)

Catalys Precision Laser System

Número K: K200056 · 2020-05-18

Data da decisão2020-05-18

Código do produtoOOE

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Catalys Precision Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Amo Manufacturng USA, LLC. It received FDA 510(k) clearance on 2020-05-18 under 510(k) number K200056. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Catalys Precision Laser System?

Catalys Precision Laser System is a medical device that received FDA 510(k) clearance on 2020-05-18. The listed applicant is Amo Manufacturng USA, LLC. The 510(k) number is K200056.

When did Catalys Precision Laser System receive FDA 510(k) clearance?

Catalys Precision Laser System received FDA 510(k) clearance on 2020-05-18, under 510(k) number K200056.

Who is the listed applicant for Catalys Precision Laser System?

The FDA 510(k) record lists Amo Manufacturng USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Catalys Precision Laser System?

The FDA product code for Catalys Precision Laser System is OOE.

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: OOE)

K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC K220259Sistema de Tratamento de Catarata ADAPTIVO ALLYLensar, Inc.K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC

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.