Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K181796 |
Device Name |
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions |
Applicant |
Alcon Laboratories, Inc. |
6201 South Freeway |
Fort Worth,
TX
76134 -2099
|
|
Applicant Contact |
Sherri Lakota |
Correspondent |
Alcon/CIBA Vision GmbH |
Industriering 1 |
Grosswallstadt,
DE
63868
|
|
Correspondent Contact |
Andreas Friese |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 07/05/2018 |
Decision Date | 08/03/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|