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FDA 510(k)

ACUVUE OASYS (senofilcon A) with Photochromic Additive

K-Number: K180299 · 2018-04-10

ApplicantJohnson & Johnson Vision Care, Inc.
Decision Date2018-04-10
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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

When was ACUVUE OASYS (senofilcon A) with Photochromic Additive approved by the FDA?

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

What company makes ACUVUE OASYS (senofilcon A) with Photochromic Additive?

ACUVUE OASYS (senofilcon A) with Photochromic Additive is manufactured by Johnson & Johnson Vision Care, Inc..

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.

Other Devices by Johnson & Johnson Vision Care, Inc.

K160212ACUVUE (senofilcon C) Soft Contact Lens 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

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

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