# K243487: CryoFreeze Wart and Skin Tag Remover

- Pathway: 510(k) (Traditional)
- Applicant: Cryosurgery, Inc.
- Decided: Mar 13, 2025 after 125 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: 5 generations back to K881349 (1988). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211099: Freeze’n Clear Skin Clinic Warts & Tags, Cryoconcepts LP (2022) Summary page 5.

## Most influential descendants
- K253000: CryoFreeze Wart and Skin Tag Remover (2025), 0 descendants of its own

## Indications for use
The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years or older.

Source page: https://510kreport.com/device/K243487
Methodology: https://510kreport.com/methodology