Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102
FDA 510(k) K162218 · Nuance Medical, LLC
510(k) numberK162218
Submission
- Device name
- Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102
- Applicant
- Nuance Medical, LLC
Carlsbad, CA, US - Received
- August 8, 2016
- Decision date
- November 22, 2016
- 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
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|---|---|---|---|
| K261684 | FreezeSpray TAMLY · Traditional | Cryosurgery, Inc. | 09/05/2026SE |
| K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | Gebauer Company | 08/27/2026SE |
| 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 |
More from Itw Contamination Control Electronics
| 510(k) | Device | Decision |
|---|---|---|
| K232674 | PainFreeze IIMLY · Traditional | 02/12/2024SE |
| K210310 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitGEH · Traditional | 10/22/2021SE |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayMLY · Traditional | 10/18/2017SE |
| K161337 | CryoDose H or SimilarGEH · Traditional | 07/12/2016SE |
| K130995 | Nuance Cryo-Freeze Spray or Cryo-In-A-Can or Vandolay Freeze SprayGEH · Traditional | 06/14/2013SE |
Questions and answers
When was Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102 cleared by the FDA?
Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102 (K162218) received a 510(k) decision of Substantially Equivalent on November 22, 2016, 106 days after the submission was received.
What is the product code of K162218?
The FDA product code is MLY – Vapocoolant Device, a Unclassified device.