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FDA 510(k)

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

Número K: K161124 · 2016-08-26

RequerenteVision Science Co., Ltd.
Data da decisão2016-08-26
Código do produtoLPL
Comité consultivoOP
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

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