# K233347: Verruca-Freeze® H

- Pathway: 510(k) (Traditional)
- Applicant: Cryosurgery, Inc.
- Decided: Dec 4, 2023 after 66 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 K990877 (1999). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161337: CryoDose H or Similar, Nuance Medical, LLC (2016) Summary page 5.

## Most influential descendants
- K243454: Verruca-Freeze H (2024), 1 descendant of its own
- K252903: Verruca-Freeze H Plus (2025), 0 descendants of its own

## Indications for use
The Verruca-Freeze® H cryosurgical system is indicated for use in the treatment of the following skin lesions: • Actinic Keratosis • Genital Warts • Lentigo • Molluscum Contagiosum • Seborrheic Keratosis • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana

Source page: https://510kreport.com/device/K233347
Methodology: https://510kreport.com/methodology