The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Air Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal.
| Device ID | K133176 |
| 510k Number | K133176 |
| Device Name: | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
| Contact | Martina Heim, Ph.d., Rac |
| Correspondent | Martina Heim, Ph.d., Rac CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-01-29 |
| Summary: | summary |