Product code MLY
- Device name
- Vapocoolant Device
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243654 | DentalJect | Vapocoolshot, Inc. | 2025-05-30 |
| K232674 | PainFreeze II | Nuance Medical, LLC | 2024-02-12 |
| K203661 | CRYO Arctic, CRYO Penguin | Cryoscience North America, Inc. | 2022-05-25 |
| K202782 | num Vapocoolant | 623 Medical, LLC | 2020-12-21 |
| K201248 | Syringe Holder accessory | Vapocoolshot, Inc. | 2020-08-12 |
| K193349 | Vapocoolshot Mist | Vapocoolshot, Inc. | 2020-04-14 |
| 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 | 2019-05-07 |
| K172598 | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE | Itw Contamination Control Electronics | 2018-04-19 |
| K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company | 2017-10-27 |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | Nuance Medical, LLC | 2017-10-18 |
| K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 | Nuance Medical, LLC | 2016-11-22 |
| K093951 | OUCHLESS MODEL PN10114 | Occam Design | 2010-06-15 |
| K033720 | ARI COLD SPRAY | Ari | 2005-06-10 |
| K032671 | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 | Gebauer Co. | 2004-03-17 |
| K030281 | CRYOTRON 2 CRYOTHERAPY DEVICE | Cryonic Medical North America | 2003-08-20 |
| 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. | 2003-07-10 |
| K021726 | GEBAUER'S INSTANT ICE | Gebauer Co. | 2002-12-12 |
| K002596 | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 | Gebauer Co. | 2001-02-15 |
| K001624 | GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 | Gebauer Co. | 2001-01-25 |
| K992286 | DERMAFREEZE | Rhealm Pharmaceuticals, Inc. | 2000-01-21 |
| K984564 | ETHYL CHLORIDE DISPENSER | Dukal Corp. | 1999-12-02 |
| K991514 | GEBAUER'S CHLORIDE FINE NOZZE | Gebauer Co. | 1999-07-16 |
| K930915 | FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE | Gebauer Co. | 1994-09-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10723797170615 | InstaNumb | BEUTLICH PHARMACEUTICALS, LLC | 2026-04-15 |
| 10723797170721 | InstaNumb | BEUTLICH PHARMACEUTICALS, LLC | 2026-04-15 |
| 10723797170837 | InstaNumb | BEUTLICH PHARMACEUTICALS, LLC | 2026-04-15 |
| 10723797170943 | InstaNumb | BEUTLICH PHARMACEUTICALS, LLC | 2026-04-15 |
| 10723797806446 | Hurri-Freeze | BEUTLICH PHARMACEUTICALS, LLC | 2025-12-15 |
| 10723797807443 | Hurri-Freeze | BEUTLICH PHARMACEUTICALS, LLC | 2025-12-15 |
| 10723797809447 | Hurri-Freeze | BEUTLICH PHARMACEUTICALS, LLC | 2025-12-15 |
| 00860006961534 | Coolject 1-3cc Syringe Holder Nozzle Accessory | Vapocoolshot, Inc | 2023-01-27 |
| 00860006961527 | Coolject Topical Anesthetic Canister | Vapocoolshot, Inc | 2023-01-27 |
| 20860006961521 | Coolject Topical Anesthetic Canister | Vapocoolshot, Inc | 2023-01-27 |
| 10860006961524 | Coolject Topical Anesthetic Canister | Vapocoolshot, Inc | 2023-01-27 |
| 08800073100049 | TargetCool | RecensMedical, Inc. | 2022-11-29 |
| 00850019947533 | Dermal Cooling System | R2 Technologies, Inc. | 2022-02-01 |
| 08800073100018 | TargetCool | RecensMedical, Inc. | 2021-06-25 |
| 00850019947182 | Dermal Cooling System | R2 Technologies, Inc. | 2021-03-31 |
| 00850019947014 | Dermal Cooling System | R2 Technologies, Inc. | 2021-03-31 |
| 00850019947007 | Dermal Cooling System | R2 Technologies, Inc. | 2021-03-31 |
| 00303860010012 | Gebauer's Instant Ice | GEBAUER COMPANY | 2020-02-27 |
| 00303860008040 | Gebauer's Pain Ease Medium Stream | GEBAUER COMPANY | 2020-02-27 |
| 00303860008033 | Gebauer's Pain Ease Medium Stream | GEBAUER COMPANY | 2020-02-27 |
| 00303860008026 | Gebauer's Pain Ease Mist Spray | GEBAUER COMPANY | 2020-02-27 |
| 00303860008019 | Gebauer's Pain Ease Mist Spray | GEBAUER COMPANY | 2020-02-27 |
| 00303860004042 | Gebauer's Spray and Stretch | GEBAUER COMPANY | 2020-02-27 |
| 00303860001133 | Gebauer's Ethyl Chloride Fine Spray Accu-Stream 360 | GEBAUER COMPANY | 2020-02-27 |
| 00303860001119 | Gebauer's Ethyl Chloride Medium Spray Accu-Stream 360 | GEBAUER COMPANY | 2020-02-27 |
| 00303860001034 | Gebauer's Ethyl Chloride Medium Spray | GEBAUER COMPANY | 2020-02-19 |
| 00347682230173 | Medi-First Cold Spray | Medique Products | 2019-07-12 |
| 00347682030056 | Green Guard Cold Spray | Greenguard | 2019-06-26 |
| 10612479220598 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2017-08-02 |
| 10612479220574 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2017-08-02 |