FDA Product Code MLY: Vapocoolant Device
Leading manufacturers include Vapocoolshot, Inc., Itw Contamination Control Electronics and Gebauer Company.
23
Total
23
Cleared
213d
Avg days
1994
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times:
185d avg (recent)
FDA 510(k) Cleared Vapocoolant Device Devices (Product Code MLY)
23 devices
Cleared
May 30, 2025
DentalJect
Vapocoolshot, Inc.
Dental
185d
Cleared
Feb 12, 2024
PainFreeze II
Nuance Medical, LLC
Physical Medicine
164d
Cleared
May 25, 2022
CRYO Arctic, CRYO Penguin
Cryoscience North America, Inc.
Physical Medicine
526d
Cleared
Dec 21, 2020
num Vapocoolant
623 Medical, LLC
Physical Medicine
90d
Cleared
Aug 12, 2020
Syringe Holder accessory
Vapocoolshot, Inc.
Physical Medicine
93d
Cleared
Apr 14, 2020
Vapocoolshot Mist
Vapocoolshot, Inc.
Physical Medicine
133d
Cleared
May 07, 2019
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
Physical Medicine
97d
Cleared
Apr 19, 2018
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
Itw Contamination Control Electronics
Physical Medicine
233d
About Product Code MLY - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code MLY since 1994, with 23 receiving FDA clearance (average review time: 213 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - MLY Product Code
FDA review times for MLY submissions have been consistent, averaging 185 days recently vs 214 days historically.
MLY devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →