FDA 510(k)

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)

Numéro K : K210930 · 2021-11-29

DemandeurJohnson & Johnson Vision Care, Inc.

Date de décision2021-11-29

Code produitLPL

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) 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 2021-11-29 under 510(k) number K210930. 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 MAX 1-DAY Contact Lenses (senofilcon A)?

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) is a medical device that received FDA 510(k) clearance on 2021-11-29. The listed applicant is Johnson & Johnson Vision Care, Inc.. The 510(k) number is K210930.

When did ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) receive FDA 510(k) clearance?

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) received FDA 510(k) clearance on 2021-11-29, under 510(k) number K210930.

Who is the listed applicant for ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)?

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 MAX 1-DAY Contact Lenses (senofilcon A)?

The FDA product code for ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) is LPL.

Essais cliniques associés

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

K200243ACUVUE (senofilcon A) Soft Contact Lens Multifocal K180299ACUVUE OASYS (senofilcon A) with Photochromic Additive K160212ACUVUE (senofilcon C) Soft Contact Lens

Dispositifs connexes (Code : LPL)

Source officielle

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