# K240226: Pixie Skin Tag

- Pathway: 510(k) (Traditional)
- Applicant: Oystershell NV
- Decided: Oct 18, 2024 after 266 days
- Product code: ORE
- 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.
1 later device descends from it; 1 cites it directly.
0 of 15 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.

## Most influential descendants
- K253000: CryoFreeze Wart and Skin Tag Remover (2025), 0 descendants of its own

## Indications for use
Pixie® Skin Tag is a cryogenic device for home use intended to treat skin tags in persons over the age of 21.

Source page: https://510kreport.com/device/K240226
Methodology: https://510kreport.com/methodology