The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Air Optix Plus Hydraglyde, Air Optix Plus Hydraglyde For Astigmatism, Air Optix Plus Hydraglyde Multifocal, Air Optix Plus Hydraglyde Multifocal Toric.
| Device ID | K160609 |
| 510k Number | K160609 |
| Device Name: | AIR OPTIX Plus HydraGlyde, AIR OPTIX Plus HydraGlyde For Astigmatism, AIR OPTIX Plus HydraGlyde Multifocal, AIR OPTIX Plus HydraGlyde Multifocal Toric |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
| Contact | Alicia M. Plesnarski |
| Correspondent | Alicia M. Plesnarski 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 | 2016-03-03 |
| Decision Date | 2016-05-02 |
| Summary: | summary |