# K211099: Freeze’n Clear Skin Clinic Warts & Tags

- Pathway: 510(k) (Traditional)
- Applicant: Cryoconcepts LP
- Decided: Jun 17, 2022 after 430 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: 4 generations back to K881349 (1988). 12 ancestors in all.
8 later devices descend from it; 7 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023487: Histofreezer Wart Removal System or Other Proprietary Name, OraSure Technologies, Inc. (2003) Summary page 4.
- K933327: Histofreezer, Solarcare, Inc. (1993) Summary page 4.
- K190747: Claritag, Dgi Technologies (2019) Summary page 4.

## Most influential descendants
- K242932: Skin Clinic Nitro Clear Wart Remover (2025), 1 descendant of its own
- K243487: CryoFreeze Wart and Skin Tag Remover (2025), 1 descendant of its own
- K240226: Pixie Skin Tag (2024), 1 descendant of its own
- K252198: Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (2026), 0 descendants of its own
- K253000: CryoFreeze Wart and Skin Tag Remover (2025), 0 descendants of its own

## Indications for use
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.

Source page: https://510kreport.com/device/K211099
Methodology: https://510kreport.com/methodology