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FDA 510(k)

SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens

N.º K: K151847 · 2016-03-04

SolicitanteSmart Performer Corp. , Ltd.
Fecha de decisión2016-03-04
Código de productoLPL
Comité asesorOP
DecisiónSubstantially Equivalent

Resumen del dispositivo

SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Smart Performer Corp. , Ltd.. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K151847. 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 SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens?

SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Smart Performer Corp. , Ltd.. The 510(k) number is K151847.

When did SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens receive FDA 510(k) clearance?

SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2016-03-04, under 510(k) number K151847.

Who is the listed applicant for SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens?

The FDA 510(k) record lists Smart Performer Corp. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens?

The FDA product code for SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is LPL.

Ensayos clínicos relacionados

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Otros registros que enlistan a Smart Performer Corp. , Ltd. 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.

K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens

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.

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