# K162218: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102

- Pathway: 510(k) (Traditional)
- Applicant: Nuance Medical, LLC
- Decided: Nov 22, 2016 after 106 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.
3 later devices descend from it; 2 cite it directly.
0 of 8 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
- K232674: PainFreeze II (2024), 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

## Indications for use
Pain Freeze™ Mist Spray and Medium Stream Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Pain Freeze™ controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). Pain Freeze™ Medium Stream Spray is also intended for the management of myofascial pain, restricted motion and muscle tension.

Source page: https://510kreport.com/device/K162218
Methodology: https://510kreport.com/methodology