MLY — Vapocoolant Device Class U
FDA Device Classification
Classification Details
- Product Code
- MLY
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Unknown
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243654 | vapocoolshot | DentalJect | May 30, 2025 |
| K232674 | nuance medical | PainFreeze II | February 12, 2024 |
| K203661 | cryoscience north america | CRYO Arctic, CRYO Penguin | May 25, 2022 |
| K202782 | 623 medical | num Vapocoolant | December 21, 2020 |
| K201248 | vapocoolshot | Syringe Holder accessory | August 12, 2020 |
| K193349 | vapocoolshot | Vapocoolshot Mist | April 14, 2020 |
| K190161 | gebauer | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chlo | May 7, 2019 |
| K172598 | itw contamination control electronics | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic | April 19, 2018 |
| K172028 | gebauer | Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium S | October 27, 2017 |
| K172203 | nuance medical | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | October 18, 2017 |
| K162218 | nuance medical | Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model | November 22, 2016 |
| K093951 | occam design | OUCHLESS MODEL PN10114 | June 15, 2010 |
| K033720 | ari | ARI COLD SPRAY | June 10, 2005 |
| K032671 | gebauer | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPR | March 17, 2004 |
| K030281 | cryonic medical north america | CRYOTRON 2 CRYOTHERAPY DEVICE | August 20, 2003 |
| K031036 | gebauer | GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN | July 10, 2003 |
| K021726 | gebauer | GEBAUER'S INSTANT ICE | December 12, 2002 |
| K002596 | gebauer | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 | February 15, 2001 |
| K001624 | gebauer | GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 | January 25, 2001 |
| K992286 | rhealm pharmaceuticals | DERMAFREEZE | January 21, 2000 |