The following data is part of a premarket notification filed by Optos Plc with the FDA for Optos Oct/slo Microperimeter.
| Device ID | K121043 |
| 510k Number | K121043 |
| Device Name: | OPTOS OCT/SLO MICROPERIMETER |
| Classification | Tomography, Optical Coherence |
| Applicant | OPTOS PLC 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Contact | Randy J Prebula |
| Correspondent | Randy J Prebula OPTOS PLC 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-05 |
| Decision Date | 2013-02-22 |
| Summary: | summary |