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

- Pathway: 510(k) (Traditional)
- Applicant: Gebauer Company
- Decided: Aug 27, 2026 after 163 days
- Product code: MLY (Vapocoolant Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K991514 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172028: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray), Gebauer Company (2017) Summary page 6.
- K232674: PainFreeze II, Nuance Medical, LLC (2024) Summary page 6.

## Indications for use
Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray): a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Gebauer's Pain Ease controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).

Source page: https://510kreport.com/device/K260870
Methodology: https://510kreport.com/methodology