MLY
- Product code
- MLY
- Device name
- Vapocoolant Device
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 24 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260870 | 2026-08-27 | Gebauer Company | Gebauer's Pain Ease Topical Anesthetic Skin Refriger… | |
| K243654 | 2025-05-30 | Vapocoolshot, Inc. | DentalJect | |
| K232674 | 2024-02-12 | Nuance Medical, LLC | PainFreeze II |
Official FDA classification page: MLY
Classification and pathway per current FDA publications. Data from openFDA (CC0).