The following data is part of a premarket notification filed by Ophthalmic Labs, Inc. with the FDA for Ovision Imaging System.
| Device ID | K200275 |
| 510k Number | K200275 |
| Device Name: | OVision Imaging System |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Ophthalmic Labs, Inc. 18 Berlin Ave Milton, MA 02186 |
| Contact | Matthew Carnevale |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2020-03-03 |