Medical Device Manufacturer · US , Fort Worth , TX

Alcon Laboratories, Inc.

43 submissions · 42 cleared · Since 1996
43
Total
42
Cleared
0
Denied

Alcon Laboratories, Inc. — FDA 510(k) Submissions

Alcon Laboratories, Inc. has submitted 43 FDA 510(k) premarket notifications since 1996, of which 42 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lenses, Soft Contact, Daily Wear, Ophthalmic Femtosecond Laser, Unit, Phacofragmentation, Accessories, Soft Lens Products, Aberrometer, Ophthalmic . Use the specialty filter in the sidebar to narrow results.

43 devices
1–25 of 43
DAILIES TOTAL1?; DAILIES TOTAL1? Multifocal
K254052 · LPL Lenses, Soft Contact,... · Ophthalmic
Feb 2026 58d
LenSx Laser System (8065000944)
K252682 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Sep 2025 30d
LenSx Laser System (8065998162)
K243896 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Apr 2025 131d
Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric
K243909 · LPL Lenses, Soft Contact,... · Ophthalmic
Jan 2025 25d
Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
K242184 · MPA Endoilluminator · Ophthalmic
Dec 2024 132d
UNITY VCS (8065000296); UNITY CS (8065000297)
K233876 · HQC Unit, Phacofragmentation · Ophthalmic
Jun 2024 197d
Centurion? Vision System (Active Sentry?) (8065753057)
K233902 · HQC Unit, Phacofragmentation · Ophthalmic
Jan 2024 30d
Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
K233856 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2023 24d
DAILIES TOTAL1?; DAILIES TOTAL1? Toric; DAILIES TOTAL1? Multifocal; DAILIES TOTAL1? Multifocal Toric
K232921 · LPL Lenses, Soft Contact,... · Ophthalmic
Nov 2023 58d
Precision1, Precision1 for Astigmatism
K230785 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2023 29d
AIR OPTIX COLORS
K222500 · LPL Lenses, Soft Contact,... · Ophthalmic
Sep 2022 28d
Alcon (serafilcon A) soft contact lenses for daily wear
K212806 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2021 116d
CLAREON MONARCH IV IOL Delivery System
K212039 · MSS Folders And Injectors,... · Ophthalmic
Aug 2021 54d
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
K210436 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2021 59d
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202448 · MVN Lens, Contact, (disposable) · Ophthalmic
Sep 2020 27d
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202036 · MVN Lens, Contact, (disposable) · Ophthalmic
Aug 2020 29d
AOCup Lens Case with AODisc
K191795 · LPN Accessories, Soft Lens... · Ophthalmic
Jul 2019 28d
WaveLight FS200 Patient Interface
K190392 · GEX Powered Laser Surgical... · Ophthalmic
Mar 2019 35d
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
K190045 · LPL Lenses, Soft Contact,... · Ophthalmic
Feb 2019 28d
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
K182782 · LPL Lenses, Soft Contact,... · Ophthalmic
Jan 2019 109d
Precision1
K182902 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2018 56d
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal
K181454 · LPL Lenses, Soft Contact,... · Ophthalmic
Nov 2018 170d
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
K181796 · LPL Lenses, Soft Contact,... · Ophthalmic
Aug 2018 29d
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
K180669 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2018 44d
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal
K180398 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2018 56d
Filters
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