Vapocoolshot Mist
510(k) K193349
Vapocoolshot Mist is a medical device (FDA unclassified; FDA product code MLY, Vapocoolant Device) made by Vapocoolshot, Inc, cleared under FDA 510(k) K193349 on 14 Apr 2020, 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 | NumberK193349 | Date14 Apr 2020 | StatusActive |
Official records
- FDA 510(k) database K193349
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MLY
- FDA applicant
- Vapocoolshot, Inc.
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K193349
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 | |||
|---|---|---|---|---|
| Coolject Standard Nozzle Accessory VM01100-00 | VM01100-00 | 00860006961541 | No longer on the market | |
| Coolject Standard Nozzle Accessory VM01100-00 | VM01100-00 | 00860006961558 | No longer on the market | |
| CoolJect Targeted-Mist Topical Anesthetic CJ02050-00 | CJ02050-00 | 00860006961589 | On the market | |
| CoolJect Targeted-Mist Topical Anesthetic CJ02050-12 | CJ02050-12 | 00860006961596 | On the market | |
| CoolJect Targeted-Mist Topical Anesthetic CJ04050-00 | CJ04050-00 / CJ04050-00 | 00860010587324 | On the market | |
| CoolJect Targeted-Mist Topical Anesthetic CJ04050-12 | CJ04050-12 / CJ04050-12 | 00860010587331 | On the market | |
| Coolject Topical Anesthetic Canister VM02000-00 | VM02000-00 | 00860006961503 | No longer on the market | |
| Coolject Topical Anesthetic Canister VM02000-03 | VM02000-03 | 00860006961527 | No longer on the market | |
| Coolject Topical Anesthetic Canister VM02000-12 | VM02000-12 | 10860006961524 | No longer on the market | |
| Coolject Topical Anesthetic Canister VM02000-24 | VM02000-24 | 20860006961521 | No longer on the market |
Similar devices
Other devices filed under FDA product code MLY (Vapocoolant Device).
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- num Vapocoolant by 623 Medical, LLC
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- FreezeSpray TA by Cryosurgery, Inc.
- DERMAFREEZE by Rhealm Pharmaceuticals, Inc.