Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Johnson & Johnson Vision Care, Inc.. It received FDA 510(k) clearance on 2016-03-28 under approval 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. It is manufactured by Johnson & Johnson Vision Care, Inc.. The 510(k) number is K160212.

When was ACUVUE (senofilcon C) Soft Contact Lens approved by the FDA?

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

What company makes ACUVUE (senofilcon C) Soft Contact Lens?

ACUVUE (senofilcon C) Soft Contact Lens is manufactured by Johnson & Johnson Vision Care, Inc..

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

NCT06749496 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear COMPLETED

Other Devices by Johnson & Johnson Vision Care, Inc.

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

Related Devices (Code: LPL)

K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. K160245Visco (olifilcon A) soft contact lensVisco Vision, Inc. K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd. K162596AIR OPTIX COLORSAlcon Laboratories, Inc. K161931Toricolors (hioxifilcon D) Soft Contact LensesPolydev , Ltd.

Official Source

View on FDA Database →

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

↑