Vapocoolant Device
FDA product code MLY · Unclassified · Physical Medicine
25510(k) clearances
0PMA approvals
7recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261684 | FreezeSpray TAMLY · Traditional | Cryosurgery, Inc. | 09/05/2026SE |
| K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | Gebauer Company | 08/27/2026SE |
| K243654 | DentalJectMLY · Traditional | Vapocoolshot, Inc. | 05/30/2025SE |
| K232674 | PainFreeze IIMLY · Traditional | Nuance Medical, LLC | 02/12/2024SE |
| K203661 | CRYO Arctic, CRYO PenguinMLY · Traditional | Cryoscience North America, Inc. | 05/25/2022SE |
| K202782 | num VapocoolantMLY · Traditional | 623 Medical, LLC | 12/21/2020SE |
| K201248 | Syringe Holder accessoryMLY · Traditional | Vapocoolshot, Inc. | 08/12/2020SE |
| K193349 | Vapocoolshot MistMLY · Traditional | Vapocoolshot, Inc. | 04/14/2020SE |
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride…MLY · Traditional | Gebauer Company | 05/07/2019SE |
| K172598 | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream…MLY · Traditional | Itw Contamination Control Electronics | 04/19/2018SE |
| K172028 | Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | Gebauer Company | 10/27/2017SE |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayMLY · Traditional | Nuance Medical, LLC | 10/18/2017SE |
| K162218 | Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102MLY · Traditional | Nuance Medical, LLC | 11/22/2016SE |
| K093951 | Ouchless Model PN10114MLY · Traditional | Occam Design | 06/15/2010SE |
| K033720 | Ari Cold SprayMLY · Traditional | Ari | 06/10/2005SE |
| K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…MLY · Traditional | Gebauer Co. | 03/17/2004SE |
| K030281 | Cryotron 2 Cryotherapy DeviceMLY · Traditional | Cryonic Medical North America | 08/20/2003SE |
| K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin…MLY · Traditional | Gebauer Co. | 07/10/2003SE |
| K021726 | Gebauer's Instant IceMLY · Traditional | Gebauer Co. | 12/12/2002SE |
| K002596 | Gebauer's Fluro Ethyl, Model 0386-0002-09MLY · Traditional | Gebauer Co. | 02/15/2001SE |
| K001624 | Gebauer's Fluori-Methane, Model 0386-0003-04MLY · Traditional | Gebauer Co. | 01/25/2001SE |
| K992286 | DermafreezeMLY · Traditional | Rhealm Pharmaceuticals, Inc. | 01/21/2000SE |
| K984564 | Ethyl Chloride DispenserMLY · Traditional | Dukal Corp. | 12/02/1999SE |
| K991514 | Gebauer's Chloride Fine NozzeMLY · Traditional | Gebauer Co. | 07/16/1999SE |
| K930915 | Fluori Methane Ss- a Vapocoolant/Skin Ref. DeviceMLY · Traditional | Gebauer Co. | 09/29/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0218-2009 | Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N…Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out… | Gebauer Company | 09/03/2008Terminated |
| Z-1062-2007 | Gebauer''s Pain Ease Sample Spray -Topical Anesthtic Skin Refrigerant is a vapocoolant…Mold contamination | Gebauer Company | 04/17/2007Terminated |
| Z-1061-2007 | Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant…Mold contamination | Gebauer Company | 04/17/2007Terminated |
| Z-1060-2007 | Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and…Mold contamination | Gebauer Company | 04/17/2007Terminated |
| Z-1059-2007 | Gebauer''s Instant Ice Mist- is used like ice for the temporary relief and reduction of…Mold contamination | Gebauer Company | 04/17/2007Terminated |
| Z-1058-2007 | Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is…Mold contamination | Gebauer Company | 04/17/2007Terminated |
| Z-1057-2007 | Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant…Mold contamination | Gebauer Company | 04/17/2007Terminated |