FDA 510(k) Applications Submitted by Alcon Laboratories, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K142284 08/18/2014 CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE ALCON LABORATORIES, INC.
K182902 10/16/2018 Precision1 Alcon Laboratories, Inc.
K160609 03/03/2016 AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric Alcon Laboratories, Inc.
K121555 05/25/2012 CENTURION VISION SYSTEM ALCON LABORATORIES, INC.
K023249 09/30/2002 ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM ALCON LABORATORIES, INC.
K190045 01/09/2019 DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives Alcon Laboratories, Inc.
K161288 05/09/2016 LenSX Laser System ALCON LABORATORIES, INC.
K173660 11/29/2017 LenSx Laser System Alcon Laboratories, Inc.
K163551 12/19/2016 LenSx Laser System Alcon Laboratories, Inc.
K212039 06/30/2021 CLAREON MONARCH IV IOL Delivery System ALCON LABORATORIES, INC.
K191795 07/03/2019 AOCup Lens Case with AODisc Alcon Laboratories, Inc.
K173538 11/15/2017 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc.
K172600 08/30/2017 AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal Alcon Laboratories, Inc.
K182782 10/01/2018 DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric Alcon Laboratories, Inc.
K021566 05/13/2002 INFINITI ALCON LABORATORIES, INC.
K190392 02/19/2019 WaveLight FS200 Patient Interface Alcon Laboratories, Inc.
K960261 01/18/1996 PALLIKARIS BRUSH ALCON LABORATORIES, INC.
K000637 02/25/2000 CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) ALCON LABORATORIES, INC.
K180398 02/13/2018 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal Alcon Laboratories, Inc.
K180669 03/14/2018 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal Alcon Laboratories, Inc.
K230785 03/22/2023 Precision1, Precision1 for Astigmatism Alcon Laboratories, Inc.
K161391 05/19/2016 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives ALCON LABORATORIES, INC.
K181454 06/04/2018 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal Alcon Laboratories, Inc.
K181796 07/05/2018 FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions Alcon Laboratories, Inc.
K172066 07/07/2017 DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal Alcon Laboratories, Inc.
K202036 07/23/2020 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal Alcon Laboratories, Inc.
K222500 08/18/2022 AIR OPTIX COLORS Alcon Laboratories, Inc.
K202448 08/26/2020 DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal Alcon Laboratories, Inc.
K162596 09/16/2016 AIR OPTIX COLORS Alcon Laboratories, Inc.
K162597 09/19/2016 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc.
K153642 12/21/2015 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal ALCON LABORATORIES, INC.
K153643 12/21/2015 Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives ALCON LABORATORIES, INC.


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