# K252198: Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Brands Laboratories B.V.
- Decided: Apr 2, 2026 after 262 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.
No later device cites it as a predicate yet.
0 of 14 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 6.

## Indications for use
Advanced Cryo Skin Tag Remover is intended to allow users direct access to a safe and effective method for the removal of skin tags. The device is indicated for over-the-counter (OTC) treatment in the removal of skin tags in adults aged 22 years and older.

Source page: https://510kreport.com/device/K252198
Methodology: https://510kreport.com/methodology