# K242625: Freeze Point & Private Label Versions

- Pathway: 510(k) (Traditional)
- Applicant: Cryoconcepts LP
- Decided: Oct 25, 2024 after 52 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 K911420 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 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.
- K140314: Wartie Wart Remover, Yonmedical BV (2014) Summary page 5.

## Indications for use
The Skin Clinic Freeze Point product is intended for the treatment of common and plantar warts by OTC consumers. May be used with children 4 years of age or older under adult supervision.

Source page: https://510kreport.com/device/K242625
Methodology: https://510kreport.com/methodology