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)

DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric

K-Number: K182782 · 2019-01-18

ApplicantAlcon Laboratories, Inc.
Decision Date2019-01-18
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric is a medical device manufactured by Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2019-01-18 under approval number K182782. 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 DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric?

DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Alcon Laboratories, Inc.. The 510(k) number is K182782.

When was DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric approved by the FDA?

DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric received FDA 510(k) clearance on 2019-01-18, under approval number K182782.

What company makes DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric?

DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric is manufactured by Alcon Laboratories, Inc..

What is the FDA product code for DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric?

The FDA product code for DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric is LPL.

Other Devices by Alcon Laboratories, Inc.

K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives K161288LenSX Laser System K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc K162596AIR OPTIX COLORS K160609AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric K153642DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

View all 43 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.

↑