The following data is part of a premarket notification filed by Optos Plc with the FDA for Optos Advance.
| Device ID | K113696 |
| 510k Number | K113696 |
| Device Name: | OPTOS ADVANCE |
| Classification | System, Image Management, Ophthalmic |
| Applicant | OPTOS PLC 555 13TH STREET, NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein OPTOS PLC 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-05-25 |
| Summary: | summary |