The following data is part of a premarket notification filed by Optos Plc with the FDA for Daytona Icg (p200ticg).
| Device ID | K134039 |
| 510k Number | K134039 |
| Device Name: | DAYTONA ICG (P200TICG) |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | OPTOS PLC 555 13TH STREET, NW Washington, DC 20004 |
| Contact | Randy Prebula |
| Correspondent | Randy Prebula OPTOS PLC 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2014-04-11 |