# K240106: Histofreezer V

- Pathway: 510(k) (Traditional)
- Applicant: Cryoconcepts LP
- Decided: Jun 10, 2024 after 146 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881349 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130995: Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray, Nuance Medical, LLC (2013) Summary page 4.

## Indications for use
The Histofreezer V indications for use as follows: 1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1 ,1-tri fluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

Source page: https://510kreport.com/device/K240106
Methodology: https://510kreport.com/methodology