Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
FDA 510(k) K260870 · Gebauer Company
510(k) numberK260870
Submission
- Device name
- Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
- Applicant
- Gebauer Company
Cleveland, OH, US - Received
- March 17, 2026
- Decision date
- August 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLY – Vapocoolant Device
- Device class
- Unclassified
Other 510(k)s with product code MLY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261684 | FreezeSpray TAMLY · Traditional | Cryosurgery, Inc. | 09/05/2026SE |
| K243654 | DentalJectMLY · Traditional | Vapocoolshot, Inc. | 05/30/2025SE |
| K232674 | PainFreeze IIMLY · Traditional | Nuance Medical, LLC | 02/12/2024SE |
| K203661 | CRYO Arctic, CRYO PenguinMLY · Traditional | Cryoscience North America, Inc. | 05/25/2022SE |
| K202782 | num VapocoolantMLY · Traditional | 623 Medical, LLC | 12/21/2020SE |
| K201248 | Syringe Holder accessoryMLY · Traditional | Vapocoolshot, Inc. | 08/12/2020SE |
| K193349 | Vapocoolshot MistMLY · Traditional | Vapocoolshot, Inc. | 04/14/2020SE |
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride…MLY · Traditional | Gebauer Company | 05/07/2019SE |
| K172598 | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream…MLY · Traditional | Itw Contamination Control Electronics | 04/19/2018SE |
| K172028 | Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | Gebauer Company | 10/27/2017SE |
More from Gebauer Company
| 510(k) | Device | Decision |
|---|---|---|
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride…MLY · Traditional | 05/07/2019SE |
| K172028 | Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | 10/27/2017SE |
| K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…MLY · Traditional | 03/17/2004SE |
| K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin…MLY · Traditional | 07/10/2003SE |
| K021726 | Gebauer's Instant IceMLY · Traditional | 12/12/2002SE |
| K981693 | Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model…LFD · Traditional | 08/06/2001SE |
| K002596 | Gebauer's Fluro Ethyl, Model 0386-0002-09MLY · Traditional | 02/15/2001SE |
| K001624 | Gebauer's Fluori-Methane, Model 0386-0003-04MLY · Traditional | 01/25/2001SE |
| K991514 | Gebauer's Chloride Fine NozzeMLY · Traditional | 07/16/1999SE |
| K930915 | Fluori Methane Ss- a Vapocoolant/Skin Ref. DeviceMLY · Traditional | 09/29/1994SE |
Questions and answers
When was Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) cleared by the FDA?
Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (K260870) received a 510(k) decision of Substantially Equivalent on August 27, 2026, 163 days after the submission was received.
What is the product code of K260870?
The FDA product code is MLY – Vapocoolant Device, a Unclassified device.