# K232674: PainFreeze II

- Pathway: 510(k) (Traditional)
- Applicant: Nuance Medical, LLC
- Decided: Feb 12, 2024 after 164 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: 5 generations back to K991514 (1999). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162218: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102, Nuance Medical, LLC (2016) Summary page 4.

## Most influential descendants
- K260870: Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (2026), 0 descendants of its own

## Indications for use
PainFreeze II Medium Stream and Mist Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. PainFreeze II's skin refrigerant controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical (lancing boils, incisions, drainage of small abscesses, and sutures), and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).

Source page: https://510kreport.com/device/K232674
Methodology: https://510kreport.com/methodology