# K253000: CryoFreeze Wart and Skin Tag Remover

- Pathway: 510(k) (Special)
- Applicant: Cryosurgery, Inc.
- Decided: Oct 16, 2025 after 28 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: 7 generations back to K911420 (1991). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243487: CryoFreeze Wart and Skin Tag Remover, Cryosurgery, Inc. (2025) Summary page 5.
- K242932: Skin Clinic Nitro Clear Wart Remover, Cryoconcepts LP (2025) Summary page 5.
- K240226: Pixie Skin Tag, Oystershell NV (2024) Summary page 6.

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

Source page: https://510kreport.com/device/K253000
Methodology: https://510kreport.com/methodology