Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)— 510(k) K260870
Substantially EquivalentGebauer Company
FDA 510(k) clearance K260870 for Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray), Substantially Equivalent on 2026-08-27. Applicant: Gebauer Company. Device class: Unclassified.
Summary
Gebauer Company filed Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant, listed in Mist Spray and Medium Spray versions. The product code is MLY, vapocoolant devices.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The Physical Medicine review panel handled it as a Traditional 510(k).
Gebauer filed from Cleveland, Ohio. The decision came 163 calendar days after FDA received it (March 17 to August 27, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Gebauer Company
- Product code
- Product code MLY
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
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