PainFreeze II
510(k) K232674
PainFreeze II is a medical device (FDA unclassified; FDA product code MLY, Vapocoolant Device) made by Nuance Medical, LLC, cleared under FDA 510(k) K232674 on 12 Feb 2024, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232674 | Date12 Feb 2024 | StatusActive |
Official records
- FDA 510(k) database K232674
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MLY
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K232674
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Hurri-Freeze 115mL Medium Stream | 115mL Medium Stream | 10723797807443 | — | On the market |
| Hurri-Freeze 115mL Mist | 115mL Mist | 10723797806446 | — | On the market |
| Hurri-Freeze 35mL Medium Stream | 0283-1808-44 / 35mL Medium Stream | 10723797808440 | — | On the market |
| Hurri-Freeze 35mL Mist | 35mL Mist | 10723797809447 | — | On the market |
| Hurri-Freeze HFO Topical Anesthetic Spray 115mL Medium Stream | 10175138 / 115mL Medium Stream | 10723797751388 | — | On the market |
| Hurri-Freeze HFO Topical Anesthetic Spray 35mL Medium Stream | 10175139 / 35mL Medium Stream | 10723797751395 | — | On the market |
Similar devices
Other devices filed under FDA product code MLY (Vapocoolant Device).
- Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) by Gebauer Co.
- Vapocoolshot Mist by Vapocoolshot, Inc
- GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 by Gebauer Co.
- Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE by Itw Contamination Control Electronics
- OUCHLESS MODEL PN10114 by Occam Design
- num Vapocoolant by 623 Medical, LLC
- Cryotron 2 Cryotherapy Device by Cryonic Medical North America
- CRYO Arctic, CRYO Penguin by Cryoscience North America, Inc.
- ARI COLD SPRAY by Ari
- FreezeSpray TA by Cryosurgery, Inc.