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 A) Soft Contact Lens Multifocal

K-Number: K200243 · 2020-03-17

ApplicantJohnson & Johnson Vision Care, Inc.
Decision Date2020-03-17
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ACUVUE (senofilcon A) Soft Contact Lens Multifocal is a medical device manufactured by Johnson & Johnson Vision Care, Inc.. It received FDA 510(k) clearance on 2020-03-17 under approval number K200243. 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 A) Soft Contact Lens Multifocal?

ACUVUE (senofilcon A) Soft Contact Lens Multifocal is a medical device that received FDA 510(k) clearance on 2020-03-17. It is manufactured by Johnson & Johnson Vision Care, Inc.. The 510(k) number is K200243.

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

ACUVUE (senofilcon A) Soft Contact Lens Multifocal received FDA 510(k) clearance on 2020-03-17, under approval number K200243.

What company makes ACUVUE (senofilcon A) Soft Contact Lens Multifocal?

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

What is the FDA product code for ACUVUE (senofilcon A) Soft Contact Lens Multifocal?

The FDA product code for ACUVUE (senofilcon A) Soft Contact Lens Multifocal 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 NCT07076160 Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses COMPLETED NCT06869044 A Clinical Comparison of Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 Add COMPLETED NCT07444658 Performance of Two Daily Disposable Multifocal Contact Lenses RECRUITING

Other Devices by Johnson & Johnson Vision Care, Inc.

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

↑