# K242288: Advanced Cryo Wart Remover

- Pathway: 510(k) (Traditional)
- Applicant: Medical Brands Laboratories B.V.
- Decided: Jan 21, 2025 after 172 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140314: Wartie Wart Remover, Yonmedical BV (2014) Summary page 5.
- (no number) Dr. Scholl’s Skin Tag Remover: named in the summary without a submission number

## Indications for use
The Advanced Cryo Wart Remover is designed as an over-the-counter (OTC) self-care device indicated for adults and children from the age of four years and older for the treatment of common and plantar warts.

Source page: https://510kreport.com/device/K242288
Methodology: https://510kreport.com/methodology