# K161337: CryoDose H or Similar

- Pathway: 510(k) (Traditional)
- Applicant: Nuance Medical, LLC
- Decided: Jul 12, 2016 after 60 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: 1 generation back to K990877 (1999). 1 ancestor in all.
3 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)
- K990877: Histofreezer Device, OraSure Technologies, Inc. (1999) Summary page 4.

## Most influential descendants
- K233347: Verruca-Freeze® H (2023), 2 descendants of its own
- 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 CryoDose H indications for use as follows: CrvoDose H is indicated for use in the treatment of actinic keratosis, genital warts, lentigo, mulluscum contagiosum, seborrheic keratosis, skin tags. verruca plantaris, verruca vulgaris, and verruca plana.

Source page: https://510kreport.com/device/K161337
Methodology: https://510kreport.com/methodology