The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Air Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal.
| Device ID | K172600 |
| 510k Number | K172600 |
| Device Name: | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
| Contact | Martina Heim |
| Correspondent | Martina Heim Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-30 |
| Decision Date | 2017-10-25 |
| Summary: | summary |