Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K212631 |
Device Name |
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses |
Applicant |
Contamac Ltd. |
Carlton House Shire Hill |
Saffron Walden,
GB
CB11 3AU
|
|
Applicant Contact |
Rob McGregor |
Correspondent |
EyeReg Consulting Inc. |
6119 Canter Lane |
West Linn,
OR
97068
|
|
Correspondent Contact |
Bret Andre |
Regulation Number | 886.5916
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/19/2021 |
Decision Date | 03/17/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|