Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K180299 |
Device Name |
ACUVUE OASYS (senofilcon A) with Photochromic Additive |
Applicant |
Johnson & Johnson Vision Care, Inc. |
7500 Centurion Parkway, Suite 100 |
Jacksonville,
FL
32256
|
|
Applicant Contact |
Victoria Brennand |
Correspondent |
Johnson & Johnson Vision Care, Inc. |
7500 Centurion Parkway, Suite 100 |
Jacksonville,
FL
32256
|
|
Correspondent Contact |
Victoria Brennand |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/02/2018 |
Decision Date | 04/10/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|