Product Code: MLY FDA unclassified

Vapocoolant Device

Unknown

The Vapocoolant Device is a topical spray or applicator that delivers a rapidly evaporating coolant, such as ethyl chloride or fluorocarbon, to the skin surface to produce a brief localized cooling effect used for temporary pain relief prior to minor procedures such as injections, venipuncture, or minor wound care. It is classified as Unclassified (Class U), indicating the FDA has not made a final classification determination, and no regulation number or medical specialty code is assigned. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: MLY
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243654	DentalJect	May 30, 2025	Substantially Equivalent	Vapocoolshot, Inc.
K232674	PainFreeze II	Feb 12, 2024	Substantially Equivalent	Nuance Medical, LLC
K203661	CRYO Arctic, CRYO Penguin	May 25, 2022	Substantially Equivalent	Cryoscience North America, Inc.
K202782	num Vapocoolant	Dec 21, 2020	Substantially Equivalent	623 Medical, LLC
K201248	Syringe Holder accessory	Aug 12, 2020	Substantially Equivalent	Vapocoolshot, Inc.
K193349	Vapocoolshot Mist	Apr 14, 2020	Substantially Equivalent	Vapocoolshot, Inc.
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	May 07, 2019	Substantially Equivalent	Gebauer Company
K172598	Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE	Apr 19, 2018	Substantially Equivalent	Itw Contamination Control Electronics
K172028	Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)	Oct 27, 2017	Substantially Equivalent	Gebauer Company
K172203	CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray	Oct 18, 2017	Substantially Equivalent	Nuance Medical, LLC
K162218	Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102	Nov 22, 2016	Substantially Equivalent	Nuance Medical, LLC
K093951	OUCHLESS MODEL PN10114	Jun 15, 2010	Substantially Equivalent	Occam Design
K033720	ARI COLD SPRAY	Jun 10, 2005	Substantially Equivalent	Ari
K032671	GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07	Mar 17, 2004	Substantially Equivalent	Gebauer Co.
K030281	CRYOTRON 2 CRYOTHERAPY DEVICE	Aug 20, 2003	Substantially Equivalent	Cryonic Medical North America
K031036	GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03	Jul 10, 2003	Substantially Equivalent	Gebauer Co.
K021726	GEBAUER'S INSTANT ICE	Dec 12, 2002	Substantially Equivalent	Gebauer Co.
K002596	GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09	Feb 15, 2001	Substantially Equivalent	Gebauer Co.
K001624	GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04	Jan 25, 2001	Substantially Equivalent	Gebauer Co.
K992286	DERMAFREEZE	Jan 21, 2000	Substantially Equivalent	Rhealm Pharmaceuticals, Inc.
K984564	ETHYL CHLORIDE DISPENSER	Dec 02, 1999	Substantially Equivalent	Dukal Corp.
K991514	GEBAUER'S CHLORIDE FINE NOZZE	Jul 16, 1999	Substantially Equivalent	Gebauer Co.
K930915	FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE	Sep 29, 1994	Substantially Equivalent	Gebauer Co.