The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Freshlook Handling Tint, Freshlook Colors, Freshlook Colorblends, Freshlook Dimensions.
| Device ID | K181796 |
| 510k Number | K181796 |
| Device Name: | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions |
| 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 | 2018-07-05 |
| Decision Date | 2018-08-03 |
| Summary: | summary |