K223470 is an FDA 510(k) clearance for the C50. This device is classified as a Laser, Fluorescence Caries Detection (Class II - Special Controls, product code NBL).
Submitted by Sopro (La Ciotat, FR). The FDA issued a Cleared decision on December 14, 2023, 392 days after receiving the submission on November 17, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K223470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2022 |
| Decision Date | December 14, 2023 |
| Days to Decision | 392 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NBL — Laser, Fluorescence Caries Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1745 |