# K251493: Skin Clinic Freeze Point for Warts and Skin Tags

- Pathway: 510(k) (Special)
- Applicant: Cryoconcepts LP
- Decided: May 22, 2025 after 7 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Skin Clinic Freeze Point product is intended for the treatment of common warts, plantar warts, and skin tags by OTC consumers. Treat skin tags in adults age 22 years or older

Source page: https://510kreport.com/device/K251493
Methodology: https://510kreport.com/methodology