K232674 is an FDA 510(k) clearance for the PainFreeze II. This device is classified as a Vapocoolant Device.
Submitted by Nuance Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on February 12, 2024, 164 days after receiving the submission on September 1, 2023.
This device falls under the Physical Medicine FDA review panel.
| 510(k) Number | K232674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2023 |
| Decision Date | February 12, 2024 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | MLY - Vapocoolant Device |
| Device Class | - |