The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Air Optix Colors.
Device ID | K162596 |
510k Number | K162596 |
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 | 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 | 2016-09-16 |
Decision Date | 2016-10-13 |
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 |