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FDA 510(k)

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear

N.º K: K161124 · 2016-08-26

SolicitanteVision Science Co., Ltd.
Fecha de decisión2016-08-26
Código de productoLPL
Comité asesorOP
DecisiónSubstantially Equivalent

Resumen del dispositivo

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is the device name listed in this FDA 510(k) record. The listed applicant is Vision Science Co., Ltd.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K161124. 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 EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Vision Science Co., Ltd.. The 510(k) number is K161124.

When did EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear receive FDA 510(k) clearance?

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear received FDA 510(k) clearance on 2016-08-26, under 510(k) number K161124.

Who is the listed applicant for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

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

What is the FDA product code for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

The FDA product code for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is LPL.

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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

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