Alcon Laboratories, Inc. - FDA 510(k) Cleared Devices
Recent clearances: DAILIES TOTAL1®, LenSx Laser System (8065000944), LenSx Laser System (8065998162)
43
Total
42
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alcon Laboratories, Inc. Ophthalmic ✕
43 devices
Cleared
Feb 13, 2026
DAILIES TOTAL1®
Ophthalmic
58d
Cleared
Sep 24, 2025
LenSx Laser System (8065000944)
Ophthalmic
30d
Cleared
Apr 28, 2025
LenSx Laser System (8065998162)
Ophthalmic
131d
Cleared
Jan 13, 2025
Precision1
Ophthalmic
25d
Cleared
Dec 04, 2024
Alcon 27GA Chandelier (8065000252)
Ophthalmic
132d
Cleared
Jun 21, 2024
UNITY VCS (8065000296)
Ophthalmic
197d
Cleared
Jan 10, 2024
Centurion™ Vision System (Active Sentry™) (8065753057)
Ophthalmic
30d
Cleared
Dec 29, 2023
Precision1
Ophthalmic
24d
Cleared
Nov 16, 2023
DAILIES TOTAL1®
Ophthalmic
58d
Cleared
CT
Apr 20, 2023
Precision1, Precision1 for Astigmatism
Ophthalmic
29d
Cleared
Sep 15, 2022
AIR OPTIX COLORS
Ophthalmic
28d
Cleared
CT
Dec 28, 2021
Alcon (serafilcon A) soft contact lenses for daily wear
Ophthalmic
116d
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