Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K161727 |
Device Name |
Eyenez Ophthalmic Camera |
Applicant |
EYENEZ LLC |
2619 E.COLORADO BLVD |
PASADENA,
CA
91107
|
|
Applicant Contact |
DR. KISLINGER |
Correspondent |
ACCURATE CONSULTANTS INC. |
3234 IBIS STREET |
SAN DIEGO,
CA
92103
|
|
Correspondent Contact |
GLEN FEYE |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 06/22/2016 |
Decision Date | 10/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02783807
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|