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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