K221601 is an FDA 510(k) clearance for the MS-39. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by C.S.O. S.R.L. (Scandicci, IT). The FDA issued a Cleared decision on September 1, 2023, 456 days after receiving the submission on June 2, 2022.
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 | K221601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2022 |
| Decision Date | September 01, 2023 |
| Days to Decision | 456 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| 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. |