FDA 510(k)

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

Número K: K213119 · 2022-05-13

Data da decisão2022-05-13

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Innova Vision, Inc.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K213119. 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 Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Innova Vision, Inc.. The 510(k) number is K213119.

When did Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens receive FDA 510(k) clearance?

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2022-05-13, under 510(k) number K213119.

Who is the listed applicant for Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

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

What is the FDA product code for Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

The FDA product code for Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is LPL.

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

K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens

Dispositivos Relacionados (Código: LPL)

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