Cleared Traditional

K260870 - Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)

K260870 · Gebauer Company · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
163d
Days
-
Risk

K260870 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 August 27, 2026 after a review of 163 days - an extended review cycle.

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

FDA 510(k) Submission Details - K260870

510(k) Number K260870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2026
Decision Date August 27, 2026
Days to Decision 163 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 115d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 14
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K260870.
DentalJect
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PainFreeze II
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CRYO Arctic, CRYO Penguin
K203661 · Cryoscience North America, Inc. · May 2022
num Vapocoolant
K202782 · 623 Medical, LLC · Dec 2020
Syringe Holder accessory
K201248 · Vapocoolshot, Inc. · Aug 2020
Vapocoolshot Mist
K193349 · Vapocoolshot, Inc. · Apr 2020