The following data is part of a premarket notification filed by Eyenez Llc with the FDA for Eyenez Ophthalmic Camera.
| Device ID | K161727 |
| 510k Number | K161727 |
| Device Name: | Eyenez Ophthalmic Camera |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | EYENEZ LLC 2619 E.COLORADO BLVD Pasadena, CA 91107 |
| Contact | Dr. Kislinger |
| Correspondent | Glen Feye ACCURATE CONSULTANTS INC. 3234 IBIS STREET San Diego, CA 92103 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-22 |
| Decision Date | 2016-10-04 |
| Summary: | summary |