FDA 510(k)

OxySoft (olifilcon C) silicone hydrogel soft contact lens

N.º K: K191397 · 2019-10-02

Fecha de decisión2019-10-02

Código de productoLPL

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

OxySoft (olifilcon C) silicone hydrogel soft contact lens is the device name listed in this FDA 510(k) record. The listed applicant is Visco Vision, Inc.. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K191397. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OxySoft (olifilcon C) silicone hydrogel soft contact lens?

OxySoft (olifilcon C) silicone hydrogel soft contact lens is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Visco Vision, Inc.. The 510(k) number is K191397.

When did OxySoft (olifilcon C) silicone hydrogel soft contact lens receive FDA 510(k) clearance?

OxySoft (olifilcon C) silicone hydrogel soft contact lens received FDA 510(k) clearance on 2019-10-02, under 510(k) number K191397.

Who is the listed applicant for OxySoft (olifilcon C) silicone hydrogel soft contact lens?

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

What is the FDA product code for OxySoft (olifilcon C) silicone hydrogel soft contact lens?

The FDA product code for OxySoft (olifilcon C) silicone hydrogel soft contact lens is LPL.

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

Otros registros que enlistan a Visco Vision, Inc. como solicitante

K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens K201080Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens K183670Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens K181349Vexillum (olifilcon B) con Lente de Contacto Suave de Silicona Hidrogel Tangible; Daily Breeze (olifilcon B) Lente de Contacto Suave de Silicona Hidrogel K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lens K173958OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens

Ver todos los 10 dispositivos →

Dispositivos relacionados (Código: LPL)

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.