Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K170001 |
Device Name |
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens |
Applicant |
Acuity Polymers, Inc. |
1667 Lake Avenue, Suite 354 |
Rochester,
NY
14615
|
|
Applicant Contact |
James A. Bonafini, Jr. |
Correspondent |
Acuity Polymers, Inc. |
1667 Lake Avenue, Suite 354 |
Rochester,
NY
14615
|
|
Correspondent Contact |
James A. Bonafini, Jr. |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 01/03/2017 |
Decision Date | 06/02/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|