# K103310: Cryonize TM

- Pathway: 510(k) (Traditional)
- Applicant: 3jt Enterprises, LLC
- Decided: Feb 9, 2011 after 91 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 K911420 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023487: Histofreezer Wart Removal System or Other Proprietary Name, OraSure Technologies, Inc. (2003) Summary page 1.
- K990877: Histofreezer Device, OraSure Technologies, Inc. (1999) Summary page 1.
- K971392: Histofreezer Verruca Plana, OraSure Technologies, Inc. (1997) Summary page 1.
- K933327: Histofreezer, Solarcare, Inc. (1993) Summary page 1.
- K931299: Histofreezer, Solarcare Technologies Corp,Inc. (1993) Summary page 1.
- K924114: Histofreezer, Solarcare Technologies Corp,Inc. (1993) Summary page 1.
- K911420: Histofreezer, Solarcare Technologies Corp,Inc. (1991) Summary page 1.
- K982358: Histofreezer Device, OraSure Technologies, Inc. (1998) Summary page 1.
- K982506: Verruca-Freeze Cryosurgery Delivery System, Cryosurgery, Inc. (1999) Summary page 1.
- K955083: Verruca-Freeze Cryosurgical Delivery System (Modification), Cryosurgery, Inc. (1996) Summary page 1.
- K944221: Verruca-Freeze (TM) Cryosurgical Delivery Syst, Modified, Cryosurgery, Inc. (1994) Summary page 1.
- K881349: Verruca-Freeze (TM) Cryotherapy Delivery System, Cryosurg, Inc. (1988) Summary page 1.

## Indications for use
CryoNize TM is indicated for use in the treatment of the following: Verruca Vulgaris, Verruca Plantaris, Condyloma Acuminata, Verruca Plana, Molluscum Contagiosum, Skin Tags, Seborrhoeic Keratosis, Actinic Keratosis, and Lentigo.

Source page: https://510kreport.com/device/K103310
Methodology: https://510kreport.com/methodology