FDA 510(k) Applications for Medical Device Product Code "MLY"
(Refrigerant, Topical (Vapocoolant))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K202782 | 623 Medical, LLC | num Vapocoolant | 12/21/2020 |
| K033720 | ARI | ARI COLD SPRAY | 06/10/2005 |
| K030281 | CRYONIC MEDICAL NORTH AMERICA | CRYOTRON 2 CRYOTHERAPY DEVICE | 08/20/2003 |
| K203661 | CryoScience North America, Inc. | CRYO Arctic, CRYO Penguin | 05/25/2022 |
| K984564 | DUKAL CORP. | ETHYL CHLORIDE DISPENSER | 12/02/1999 |
| K991514 | GEBAUER CO. | GEBAUER'S CHLORIDE FINE NOZZE | 07/16/1999 |
| K001624 | GEBAUER CO. | GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 | 01/25/2001 |
| K002596 | GEBAUER CO. | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 | 02/15/2001 |
| K021726 | GEBAUER CO. | GEBAUER'S INSTANT ICE | 12/12/2002 |
| K031036 | GEBAUER CO. | GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 | 07/10/2003 |
| K032671 | GEBAUER CO. | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 | 03/17/2004 |
| K190161 | Gebauer Company | 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 | 05/07/2019 |
| K172028 | Gebauer Company | GebauerÆs Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | 10/27/2017 |
| K172598 | ITW Contamination Control Electronics | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE | 04/19/2018 |
| K172203 | Nuance Medical, LLC | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | 10/18/2017 |
| K162218 | NUANCE MEDICAL, LLC | Pain FreezeÖ, Medium Stream Spray, Model #2101; Pain FreezeÖ, Mist Spray, Model #2102 | 11/22/2016 |
| K232674 | Nuance Medical, LLC | PainFreeze II | 02/12/2024 |
| K093951 | OCCAM DESIGN | OUCHLESS MODEL PN10114 | 06/15/2010 |
| K992286 | RHEALM PHARMACEUTICALS, INC. | DERMAFREEZE | 01/21/2000 |
| K243654 | Vapocoolshot, Inc | DentalJect | 05/30/2025 |
| K201248 | Vapocoolshot, Inc. | Syringe Holder accessory | 08/12/2020 |
| K193349 | Vapocoolshot, Inc. | Vapocoolshot Mist | 04/14/2020 |
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