FDA 510(k)

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)

Número K: K161098 · 2016-08-22

Data da decisão2016-08-22

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) is the device name listed in this FDA 510(k) record. The listed applicant is Joowon Innovation Co., Ltd.. It received FDA 510(k) clearance on 2016-08-22 under 510(k) number K161098. 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 ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)?

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is Joowon Innovation Co., Ltd.. The 510(k) number is K161098.

When did ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) receive FDA 510(k) clearance?

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) received FDA 510(k) clearance on 2016-08-22, under 510(k) number K161098.

Who is the listed applicant for ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)?

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

What is the FDA product code for ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)?

The FDA product code for ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) is LPL.

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Dispositivos Relacionados (Código: LPL)

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