# K032671: Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07

- Pathway: 510(k) (Traditional)
- Applicant: Gebauer Co.
- Decided: Mar 17, 2004 after 201 days
- Product code: MLY (Vapocoolant Device)
- Device class: U
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991514 (1999). 3 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031036: Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/N-03, Gebauer Co. (2003) Summary page 1.

## Most influential descendants
- K172028: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (2017), 4 descendants of its own
- K162218: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 (2016), 3 descendants of its own
- K232674: PainFreeze II (2024), 1 descendant of its own
- K193349: Vapocoolshot Mist (2020), 1 descendant of its own
- K261684: FreezeSpray TA (2026), 0 descendants of its own

## Recalls of this device
- Apr 17, 2007 · Not classified · Z-1057-2007: Mold contamination
- Apr 17, 2007 · Not classified · Z-1061-2007: Mold contamination
- Apr 17, 2007 · Not classified · Z-1062-2007: Mold contamination

## Indications for use
Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. Gebauer's Skin Refrigerant 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/K032671
Methodology: https://510kreport.com/methodology