Alcon Laboratories

FDA Regulatory Profile

Alcon Laboratories appears in FDA public data with 0 recalls, 90 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on February 13, 2026.

Summary

Total Recalls
0
510(k) Clearances
90
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254052DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalFebruary 13, 2026
K252682LenSx Laser System (8065000944)September 24, 2025
K243896LenSx Laser System (8065998162)April 28, 2025
K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies TotaJanuary 13, 2025
K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ December 4, 2024
K233876UNITY VCS (8065000296); UNITY CS (8065000297)June 21, 2024
K233902Centurion™ Vision System (Active Sentry™) (8065753057)January 10, 2024
K233856Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 MultifocalDecember 29, 2023
K232921DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal ToricNovember 16, 2023
K230785Precision1, Precision1 for AstigmatismApril 20, 2023
K222500AIR OPTIX COLORSSeptember 15, 2022
K212806Alcon (serafilcon A) soft contact lenses for daily wearDecember 28, 2021
K212039CLAREON MONARCH IV IOL Delivery SystemAugust 23, 2021
K210436Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 AsphereApril 12, 2021
K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalSeptember 22, 2020
K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / August 21, 2020
K191795AOCup Lens Case with AODiscJuly 31, 2019
K190392WaveLight FS200 Patient InterfaceMarch 26, 2019
K190045DAILIES Colors, DAILIES Colors Toric, DAILIES Colors ProgressivesFebruary 6, 2019
K182782DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DJanuary 18, 2019