MLY

FDA Product Code MLY: Vapocoolant Device

Leading manufacturers include Gebauer Co., Nuance Medical, LLC and Gebauer Company.

25
Total
25
Cleared
207d
Avg days
1994
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 152d recently vs 214d historically

FDA 510(k) Cleared Vapocoolant Device Devices (Product Code MLY)

25 devices
1–24 of 25
Cleared Sep 05, 2026
FreezeSpray TA
K261684
Cryosurgery, Inc.
Physical Medicine · 107d
Cleared Aug 27, 2026
Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
K260870
Gebauer Company
Physical Medicine · 163d
Cleared May 30, 2025
DentalJect
K243654
Vapocoolshot, Inc.
Dental · 185d
Cleared Feb 12, 2024
PainFreeze II
K232674
Nuance Medical, LLC
Physical Medicine · 164d
Cleared May 25, 2022
CRYO Arctic, CRYO Penguin
K203661
Cryoscience North America, Inc.
Physical Medicine · 526d
Cleared Dec 21, 2020
num Vapocoolant
K202782
623 Medical, LLC
Physical Medicine · 90d
Cleared Aug 12, 2020
Syringe Holder accessory
K201248
Vapocoolshot, Inc.
Physical Medicine · 93d
Cleared Apr 14, 2020
Vapocoolshot Mist
K193349
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
K190161
Gebauer Company
Physical Medicine · 97d
Cleared Apr 19, 2018
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
K172598
Itw Contamination Control Electronics
Physical Medicine · 233d
Cleared Oct 27, 2017
Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
K172028
Gebauer Company
Physical Medicine · 114d
Cleared Oct 18, 2017
CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray
K172203
Nuance Medical, LLC
Physical Medicine · 89d
Cleared Nov 22, 2016
Pain Freeze™, Medium Stream Spray, Model #2101
K162218
Nuance Medical, LLC
Physical Medicine · 106d
Cleared Jun 15, 2010
OUCHLESS MODEL PN10114
K093951
Occam Design
Physical Medicine · 174d
Cleared Aug 20, 2003
CRYOTRON 2 CRYOTHERAPY DEVICE
K030281
Cryonic Medical North America
Physical Medicine · 205d
Cleared Jul 10, 2003
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03
K031036
Gebauer Co.
Physical Medicine · 100d
Cleared Dec 12, 2002
GEBAUER'S INSTANT ICE
K021726
Gebauer Co.
Physical Medicine · 202d
Cleared Feb 15, 2001
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
K002596
Gebauer Co.
Physical Medicine · 178d
Cleared Jan 25, 2001
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
K001624
Gebauer Co.
Physical Medicine · 244d
Cleared Jan 21, 2000
DERMAFREEZE
K992286
Rhealm Pharmaceuticals, Inc.
Physical Medicine · 198d
Cleared Dec 02, 1999
ETHYL CHLORIDE DISPENSER
K984564
Dukal Corp.
Physical Medicine · 344d
Cleared Jul 16, 1999
GEBAUER'S CHLORIDE FINE NOZZE
K991514
Gebauer Co.
Physical Medicine · 77d

About Product Code MLY - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code MLY since 1994, with 25 receiving FDA clearance (average review time: 207 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MLY Product Code

Recent submissions under MLY have taken an average of 152 days to reach a decision - down from 214 days historically, suggesting improved FDA processing for this classification.

MLY devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →