Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K213538 |
Device Name |
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
Applicant |
Acuity Polymers, Inc. |
1667 Lake Ave. Suite 303 |
Rochester,
NY
14615
|
|
Applicant Contact |
James A Bonafini |
Correspondent |
Acuity Polymers, Inc. |
1667 Lake Ave. Suite 303 |
Rochester,
NY
14615
|
|
Correspondent Contact |
James A Bonafini |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 11/08/2021 |
Decision Date | 12/30/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|