PainFreeze II
K-Number: K232674 · 2024-02-12
ApplicantNuance Medical, LLC
Decision Date2024-02-12
Product CodeMLY
DecisionSubstantially Equivalent
Device Summary
PainFreeze II is a medical device manufactured by Nuance Medical, LLC. It received FDA 510(k) clearance on 2024-02-12 under approval number K232674. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PainFreeze II?
PainFreeze II is a medical device that received FDA 510(k) clearance on 2024-02-12. It is manufactured by Nuance Medical, LLC. The 510(k) number is K232674.
When was PainFreeze II approved by the FDA?
PainFreeze II received FDA 510(k) clearance on 2024-02-12, under approval number K232674.
What company makes PainFreeze II?
PainFreeze II is manufactured by Nuance Medical, LLC.
What is the FDA product code for PainFreeze II?
The FDA product code for PainFreeze II is MLY.
Other Devices by Nuance Medical, LLC
Related Devices (Code: MLY)
K162218Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102Nuance Medical, LLC
K172028Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company
K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayNuance Medical, LLC
K172598Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREEItw Contamination Control Electronics
K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine SprayGebauer Company
K202782num Vapocoolant623 Medical, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.