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The Tracker / August 2026 / K260870

510(k) cleared

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

Gebauer Company · Aug 27, 2026 · K260870

FDA cleared the Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) from Gebauer Company on Aug 27, 2026 under K260870, a traditional 510(k). The device falls under product code MLY, Vapocoolant Device as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Mar 17, 2026. The decision came 163 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Gebauer Company in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260870?

K260870 is the FDA 510(k) for Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray), submitted by Gebauer Company. FDA's decision date was Aug 27, 2026, under product code MLY (Vapocoolant Device).

Who makes the Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

Gebauer Company, based in Cleveland, OH, is the applicant of record for K260870.

How long did the K260870 review take?

FDA received the submission on Mar 17, 2026 and issued its decision on Aug 27, 2026, 163 days later.

← All decisions in August 2026