FDA 510(k)

ACUVUE OASYS (senofilcon A) with Photochromic Additive

Numéro K : K180299 · 2018-04-10

DemandeurJohnson & Johnson Vision Care, Inc.

Date de décision2018-04-10

Code produitLPL

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

ACUVUE OASYS (senofilcon A) with Photochromic Additive is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Vision Care, Inc.. It received FDA 510(k) clearance on 2018-04-10 under 510(k) number K180299. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ACUVUE OASYS (senofilcon A) with Photochromic Additive?

ACUVUE OASYS (senofilcon A) with Photochromic Additive is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Johnson & Johnson Vision Care, Inc.. The 510(k) number is K180299.

When did ACUVUE OASYS (senofilcon A) with Photochromic Additive receive FDA 510(k) clearance?

ACUVUE OASYS (senofilcon A) with Photochromic Additive received FDA 510(k) clearance on 2018-04-10, under 510(k) number K180299.

Who is the listed applicant for ACUVUE OASYS (senofilcon A) with Photochromic Additive?

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

What is the FDA product code for ACUVUE OASYS (senofilcon A) with Photochromic Additive?

The FDA product code for ACUVUE OASYS (senofilcon A) with Photochromic Additive is LPL.

Essais cliniques associés

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Autres dossiers indiquant Johnson & Johnson Vision Care, Inc. en tant que demandeur

K210930ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)K200243ACUVUE (senofilcon A) Soft Contact Lens Multifocal K160212ACUVUE (senofilcon C) Soft Contact Lens

Dispositifs connexes (Code : LPL)

Source officielle

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