# MLY · Vapocoolant Device

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/MLY

## Overview

- **Product Code:** MLY
- **Device Name:** Vapocoolant Device
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 23)

Showing 20 most recent of 23 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243654](/device/K243654.md) | DentalJect | Vapocoolshot, Inc. | May 30, 2025 | SESE |
| [K232674](/device/K232674.md) | PainFreeze II | Nuance Medical, LLC | Feb 12, 2024 | SESE |
| [K203661](/device/K203661.md) | CRYO Arctic, CRYO Penguin | Cryoscience North America, Inc. | May 25, 2022 | SESE |
| [K202782](/device/K202782.md) | num Vapocoolant | 623 Medical, LLC | Dec 21, 2020 | SESE |
| [K201248](/device/K201248.md) | Syringe Holder accessory | Vapocoolshot, Inc. | Aug 12, 2020 | SESE |
| [K193349](/device/K193349.md) | Vapocoolshot Mist | Vapocoolshot, Inc. | Apr 14, 2020 | SESE |
| [K190161](/device/K190161.md) | 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](/device/K172598.md) | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE | Itw Contamination Control Electronics | Apr 19, 2018 | SESE |
| [K172028](/device/K172028.md) | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company | Oct 27, 2017 | SESE |
| [K172203](/device/K172203.md) | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | Nuance Medical, LLC | Oct 18, 2017 | SESE |
| [K162218](/device/K162218.md) | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 | Nuance Medical, LLC | Nov 22, 2016 | SESE |
| [K093951](/device/K093951.md) | OUCHLESS MODEL PN10114 | Occam Design | Jun 15, 2010 | SESE |
| [K033720](/device/K033720.md) | ARI COLD SPRAY | Ari | Jun 10, 2005 | SESE |
| [K032671](/device/K032671.md) | 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](/device/K030281.md) | CRYOTRON 2 CRYOTHERAPY DEVICE | Cryonic Medical North America | Aug 20, 2003 | SESE |
| [K031036](/device/K031036.md) | 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](/device/K021726.md) | GEBAUER'S INSTANT ICE | Gebauer Co. | Dec 12, 2002 | SESE |
| [K002596](/device/K002596.md) | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 | Gebauer Co. | Feb 15, 2001 | SESE |
| [K001624](/device/K001624.md) | GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 | Gebauer Co. | Jan 25, 2001 | SESE |
| [K992286](/device/K992286.md) | 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

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**Source:** [https://fda.innolitics.com/productcode/MLY](https://fda.innolitics.com/productcode/MLY)

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