Device Classification Name |
Digital Visual Acuity Test
|
510(k) Number |
K220090 |
Device Name |
Visibly Digital Acuity Product |
Applicant |
Visibly, Inc. |
207 E Ohio Street, #233 |
Chicago,
IL
60611
|
|
Applicant Contact |
Paul Foley |
Correspondent |
Hogan Lovells US LLP |
1735 Market Street, 23rd Floor |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice M. Hogan |
Regulation Number | 886.1150
|
Classification Product Code |
|
Date Received | 01/11/2022 |
Decision Date | 08/12/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT05026658
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|