K231673 is an FDA 510(k) clearance for the P200TE (A10700). This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Optos Plc. (Dunfermline, GB). The FDA issued a Cleared decision on August 18, 2023, 71 days after receiving the submission on June 8, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..
| 510(k) Number | K231673 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2023 |
| Decision Date | August 18, 2023 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OBO - Tomography, Optical Coherence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |
| Definition | Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases. |