The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Air Optix Colors.
| Device ID | K222500 |
| 510k Number | K222500 |
| Device Name: | AIR OPTIX COLORS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
| Contact | Sherri Lakota |
| Correspondent | Dr.Andreas Friese Alcon/CIBA Vision GmbH Industriering 1 Grosswallstadt, DE 63868 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-18 |
| Decision Date | 2022-09-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AIR OPTIX COLORS 86609004 4894622 Live/Registered |
Novartis AG 2015-04-24 |
![]() AIR OPTIX COLORS 86257649 4674449 Live/Registered |
ALCON, INC. 2014-04-21 |