FDA 510(k)

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)

N.º K: K181050 · 2018-06-13

Fecha de decisión2018-06-13

Código de productoLPL

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) is the device name listed in this FDA 510(k) record. The listed applicant is Qualimed Srl. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K181050. 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 Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)?

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Qualimed Srl. The 510(k) number is K181050.

When did Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) receive FDA 510(k) clearance?

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) received FDA 510(k) clearance on 2018-06-13, under 510(k) number K181050.

Who is the listed applicant for Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)?

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

What is the FDA product code for Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)?

The FDA product code for Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) 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

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.