FDA 510(k) clearance · back to tracker

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

Gebauer Company cleared K260870 on 2026-08-27, decision: substantially equivalent

K-number

K260870

Sponsor

Gebauer Company

Device

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

Class

Class U

Decision

Substantially Equivalent

Decision date

2026-08-27

Product code

MLY

Advisory committee

Unknown

Medical specialty

Unknown

Regulation number

Official FDA record

Open K260870on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.