Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (K172028) - FDA 510(k) Clearance

K172028 is an FDA 510(k) clearance for the Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Mediu.... Classified as Vapocoolant Device (product code MLY).

Submitted by Gebauer Company (Cleveland, US). The FDA issued a Cleared decision on October 27, 2017 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Gebauer Company devices