K193349 is an FDA 510(k) clearance for the Vapocoolshot Mist. This device is classified as a Vapocoolant Device.
Submitted by Vapocoolshot, Inc. (Jupiter, US). The FDA issued a Cleared decision on April 14, 2020, 133 days after receiving the submission on December 3, 2019.
This device falls under the Physical Medicine FDA review panel.
| 510(k) Number | K193349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2019 |
| Decision Date | April 14, 2020 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | MLY - Vapocoolant Device |
| Device Class | - |