K231222 is an FDA 510(k) clearance for the 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2). This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Topcon Corporation (Itabashi-Ku, JP). The FDA issued a Cleared decision on October 30, 2023, 185 days after receiving the submission on April 28, 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 | K231222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2023 |
| Decision Date | October 30, 2023 |
| Days to Decision | 185 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. |