Cleared Traditional

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

K172028 · Gebauer Company · Physical Medicine device
Oct 2017
Decision
114d
Days
-
Risk

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.

Submission Details

510(k) Number K172028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2017
Decision Date October 27, 2017
Days to Decision 114 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 151d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -