Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alcon Laboratories, Inc. — Predicate Candidate Screening
43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
170 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. | 2026-02-13 | 58 | 0 |
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | 2025-09-24 | 30 | 0 |
| K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | 2025-04-28 | 131 | 0 |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dail | Alcon Laboratories, Inc. | 2025-01-13 | 25 | 0 |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle | Alcon Laboratories, Inc. | 2024-12-04 | 132 | 2 |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | 2024-06-21 | 197 | 2 |
| K233902 | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories, Inc. | 2024-01-10 | 30 | 0 |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for | Alcon Laboratories, Inc. | 2023-12-29 | 24 | 1 |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Mult | Alcon Laboratories, Inc. | 2023-11-16 | 58 | 1 |
| K230785 | Precision1, Precision1 for Astigmatism | Alcon Laboratories, Inc. | 2023-04-20 | 29 | 0 |
| K222500 | AIR OPTIX COLORS | Alcon Laboratories, Inc. | 2022-09-15 | 28 | 0 |
| K212806 | Alcon (serafilcon A) soft contact lenses for daily wear | Alcon Laboratories, Inc. | 2021-12-28 | 116 | 0 |
| K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | 2021-08-23 | 54 | 0 |
| K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total3 | Alcon Laboratories, Inc. | 2021-04-12 | 59 | 0 |
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Tori | Alcon Laboratories, Inc. | 2020-09-22 | 27 | 0 |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progress | Alcon Laboratories, Inc. | 2020-08-21 | 29 | 0 |
| K191795 | AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2019-07-31 | 28 | 0 |
| K190392 | WaveLight FS200 Patient Interface | Alcon Laboratories, Inc. | 2019-03-26 | 35 | 0 |
| K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progres | Alcon Laboratories, Inc. | 2019-02-06 | 28 | 0 |
| K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for A | Alcon Laboratories, Inc. | 2019-01-18 | 109 | 0 |
| K182902 | Precision1 | Alcon Laboratories, Inc. | 2018-12-11 | 56 | 1 |
| K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech | Alcon Laboratories, Inc. | 2018-11-21 | 170 | 0 |
| K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBl | Alcon Laboratories, Inc. | 2018-08-03 | 29 | 0 |
| K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progress | Alcon Laboratories, Inc. | 2018-04-27 | 44 | 0 |
| K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progress | Alcon Laboratories, Inc. | 2018-04-10 | 56 | 0 |
| K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018-03-27 | 118 | 0 |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case | Alcon Laboratories, Inc. | 2017-12-04 | 19 | 0 |
| K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS M | Alcon Laboratories, Inc. | 2017-10-25 | 56 | 0 |
| K172066 | DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus | Alcon Laboratories, Inc. | 2017-08-09 | 33 | 0 |
| K163551 | LenSx Laser System | Alcon Laboratories, Inc. | 2017-02-03 | 46 | 0 |
| K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DA | Alcon Laboratories, Inc. | 2016-11-30 | 195 | 0 |
| K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016-11-16 | 191 | 0 |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case | Alcon Laboratories, Inc. | 2016-10-19 | 30 | 0 |
| K162596 | AIR OPTIX COLORS | Alcon Laboratories, Inc. | 2016-10-13 | 27 | 0 |
| K160609 | AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Ast | Alcon Laboratories, Inc. | 2016-05-02 | 60 | 0 |
| K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressiv | Alcon Laboratories, Inc. | 2016-01-20 | 30 | 0 |
| K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DA | Alcon Laboratories, Inc. | 2016-01-20 | 30 | 0 |
| K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRA | Alcon Laboratories, Inc. | 2015-01-26 | 161 | 1 |
| K121555 | CENTURION VISION SYSTEM | Alcon Laboratories, Inc. | 2012-12-21 | 210 | 4 |
| K023249 | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Laboratories, Inc. | 2002-10-18 | 18 | 1 |
| K021566 | INFINITI | Alcon Laboratories, Inc. | 2002-07-02 | 50 | 3 |
| K000637 | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) | Alcon Laboratories, Inc. | 2000-05-19 | 84 | 0 |
| K960261 | PALLIKARIS BRUSH | Alcon Laboratories, Inc. | 1996-03-11 | 53 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda