Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K220070 |
Device Name |
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens |
Applicant |
CooperVision, Inc. |
6101 Bollinger Canyon Road, Suite 500 |
San Ramon,
CA
94583
|
|
Applicant Contact |
Marie Dutton |
Correspondent |
CooperVision, Inc. |
6101 Bollinger Canyon Road, Suite 500 |
San Ramon,
CA
94583
|
|
Correspondent Contact |
Marie Dutton |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/10/2022 |
Decision Date | 02/04/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|