FDA 510(k)

ACUVUE (senofilcon C) Soft Contact Lens

K-Number: K160212 · 2016-03-28

ApplicantJohnson & Johnson Vision Care, Inc.

Decision Date2016-03-28

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ACUVUE (senofilcon C) Soft Contact Lens 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 2016-03-28 under 510(k) number K160212. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUVUE (senofilcon C) Soft Contact Lens?

ACUVUE (senofilcon C) Soft Contact Lens is a medical device that received FDA 510(k) clearance on 2016-03-28. The listed applicant is Johnson & Johnson Vision Care, Inc.. The 510(k) number is K160212.

When did ACUVUE (senofilcon C) Soft Contact Lens receive FDA 510(k) clearance?

ACUVUE (senofilcon C) Soft Contact Lens received FDA 510(k) clearance on 2016-03-28, under 510(k) number K160212.

Who is the listed applicant for ACUVUE (senofilcon C) Soft Contact Lens?

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 (senofilcon C) Soft Contact Lens?

The FDA product code for ACUVUE (senofilcon C) Soft Contact Lens is LPL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06749496Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of WearCOMPLETED NCT06778057Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact LensesCOMPLETED NCT06967129Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration ProcessCOMPLETED NCT07788521Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® MultifocalNOT_YET_RECRUITING NCT06864858Clinical Evaluation of Two Cosmetic Contact LensesCOMPLETED NCT07076160Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact LensesCOMPLETED

Other records listing Johnson & Johnson Vision Care, Inc. as applicant

K210930ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)K200243ACUVUE (senofilcon A) Soft Contact Lens Multifocal K180299ACUVUE OASYS (senofilcon A) with Photochromic Additive

Related Devices (Code: LPL)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.