FDA 510(k)

ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)

Número K: K182247 · 2018-10-12

Data da decisão2018-10-12

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) is the device name listed in this FDA 510(k) record. The listed applicant is Vizionfocus, Inc.. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K182247. 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 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)?

ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Vizionfocus, Inc.. The 510(k) number is K182247.

When did ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) receive FDA 510(k) clearance?

ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) received FDA 510(k) clearance on 2018-10-12, under 510(k) number K182247.

Who is the listed applicant for ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)?

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 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)?

The FDA product code for ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) is LPL.

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Outros registros que listam Vizionfocus, Inc. como candidato(a)

K251573VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens 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 Lens K192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses

Dispositivos Relacionados (Código: LPL)

Fonte oficial

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