K250753 is an FDA 510(k) clearance for the VELMENI for DENTISTS (V4D). This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Velmeni, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 2, 2025, 174 days after receiving the submission on March 12, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2070. For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers.
| 510(k) Number | K250753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2025 |
| Decision Date | September 02, 2025 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MYN - Analyzer, Medical Image |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2070 |
| Definition | For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers |