510(k) Report

Devices descending from K162218

3 later devices reach Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261684FreezeSpray TACryosurgery, Inc.20260—
+1K232674PainFreeze IINuance Medical, LLC20241—
+2K260870Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company20260—