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)

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens

K-Number: K182249 · 2018-11-30

ApplicantBausch & Lomb, Incorporated
Decision Date2018-11-30
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is a medical device manufactured by Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2018-11-30 under approval number K182249. 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 Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens?

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Bausch & Lomb, Incorporated. The 510(k) number is K182249.

When was Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens approved by the FDA?

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens received FDA 510(k) clearance on 2018-11-30, under approval number K182249.

What company makes Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens?

Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is manufactured by Bausch & Lomb, Incorporated.

What is the FDA product code for Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens?

The FDA product code for Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is LPL.

Related Clinical Trials

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 NCT06873048 Short-term Study of Two Soft Contact Lenses in Wearers With Low Astigmatism COMPLETED NCT07303920 Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day RECRUITING

Other Devices by Bausch & Lomb, Incorporated

K161819NNR06 Multi-Purpose Solution K151918Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist K173089Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions K173365Bausch + Lomb Boston Scleral Lens Case K170483Bausch + Lomb Sensitive Eyes Plus Saline Solution K181627Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner

View all 14 devices →

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.

↑