# K172028: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)

- Pathway: 510(k) (Traditional)
- Applicant: Gebauer Company
- Decided: Oct 27, 2017 after 114 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: 4 generations back to K991514 (1999). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032671: Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07, Gebauer Co. (2004) Summary page 4.

## Most influential descendants
- K193349: Vapocoolshot Mist (2020), 1 descendant of its own
- K261684: FreezeSpray TA (2026), 0 descendants of its own
- K260870: Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (2026), 0 descendants of its own
- K201248: Syringe Holder accessory (2020), 0 descendants of its own

## 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, mucous membranes 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 the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

Source page: https://510kreport.com/device/K172028
Methodology: https://510kreport.com/methodology