MLY · Vapocoolant Device
· Class U
Overview
| Product Code | MLY |
|---|---|
| Device Name | Vapocoolant Device |
| Device Class | Class U |
| Review Panel |
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243654 | DentalJect | Vapocoolshot, Inc. | May 30, 2025 | SESE |
| K232674 | PainFreeze II | Nuance Medical, LLC | Feb 12, 2024 | SESE |
| K203661 | CRYO Arctic, CRYO Penguin | Cryoscience North America, Inc. | May 25, 2022 | SESE |
| K202782 | num Vapocoolant | 623 Medical, LLC | Dec 21, 2020 | SESE |
| K201248 | Syringe Holder accessory | Vapocoolshot, Inc. | Aug 12, 2020 | SESE |
| K193349 | Vapocoolshot Mist | Vapocoolshot, Inc. | Apr 14, 2020 | SESE |
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray | Gebauer Company | May 7, 2019 | SESE |
| K172598 | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE | Itw Contamination Control Electronics | Apr 19, 2018 | SESE |
| K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company | Oct 27, 2017 | SESE |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | Nuance Medical, LLC | Oct 18, 2017 | SESE |
| K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 | Nuance Medical, LLC | Nov 22, 2016 | SESE |
| K093951 | OUCHLESS MODEL PN10114 | Occam Design | Jun 15, 2010 | SESE |
| K033720 | ARI COLD SPRAY | Ari | Jun 10, 2005 | SESE |
| K032671 | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 | Gebauer Co. | Mar 17, 2004 | SESE |
| K030281 | CRYOTRON 2 CRYOTHERAPY DEVICE | Cryonic Medical North America | Aug 20, 2003 | SESE |
| K031036 | GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 | Gebauer Co. | Jul 10, 2003 | SESE |
| K021726 | GEBAUER'S INSTANT ICE | Gebauer Co. | Dec 12, 2002 | SESE |
| K002596 | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 | Gebauer Co. | Feb 15, 2001 | SESE |
| K001624 | GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 | Gebauer Co. | Jan 25, 2001 | SESE |
| K992286 | DERMAFREEZE | Rhealm Pharmaceuticals, Inc. | Jan 21, 2000 | SESE |
Top Applicants
- Gebauer Co. — 7 clearances
- Nuance Medical, LLC — 3 clearances
- Vapocoolshot, Inc. — 3 clearances
- Gebauer Company — 2 clearances
- 623 Medical, LLC — 1 clearance
