FDA Product Code MLY: Vapocoolant Device
Leading manufacturers include Cryoscience North America, Inc., Nuance Medical, LLC and Vapocoolshot, Inc..
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
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 Review Time
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 →