K232674
- 510(k) number
- K232674
- Device name
- PainFreeze II
- Applicant
- Nuance Medical, LLC CA · US
- Product code
- MLY — Vapocoolant Device
- Decision date
- 2024-02-12
- Date received
- 2023-09-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232674.pdf
Official FDA record: K232674
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.