FDA 510(k)

Catalys Precision Laser System

N.º K: K200056 · 2020-05-18

Fecha de decisión2020-05-18

Código de productoOOE

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.