K162218 is an FDA 510(k) clearance for the Pain Freeze™, Medium Stream Spray, Model #2101. This device is classified as a Vapocoolant Device.
Submitted by Nuance Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on November 22, 2016, 106 days after receiving the submission on August 8, 2016.
This device falls under the Physical Medicine FDA review panel.
| 510(k) Number | K162218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2016 |
| Decision Date | November 22, 2016 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | MLY - Vapocoolant Device |
| Device Class | - |