Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens

N.º K: K251573 · 2025-09-10

SolicitanteVizionfocus, Inc.
Fecha de decisión2025-09-10
Código de productoLPL
Comité asesorOP
DecisiónSubstantially Equivalent

Resumen del dispositivo

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Vizionfocus, Inc.. It received FDA 510(k) clearance on 2025-09-10 under 510(k) number K251573. 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 VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens?

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2025-09-10. The listed applicant is Vizionfocus, Inc.. The 510(k) number is K251573.

When did VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens receive FDA 510(k) clearance?

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2025-09-10, under 510(k) number K251573.

Who is the listed applicant for VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens?

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

What is the FDA product code for VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens?

The FDA product code for VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Vizionfocus, Inc. como solicitante

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.

K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)K242413VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact LensK192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact LensesK182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)

Dispositivos relacionados (Código: LPL)

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.

K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSESGEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.

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.

↑