# K190747: Claritag

- Pathway: 510(k) (Traditional)
- Applicant: Dgi Technologies
- Decided: Oct 31, 2019 after 223 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: 3 generations back to K881349 (1988). 5 ancestors in all.
9 later devices descend from it; 2 cite 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)
- K161296: Cool Renewal, Cool Renewal, LLC (2016) Summary page 4.

## Most influential descendants
- K211099: Freeze’n Clear Skin Clinic Warts & Tags (2022), 8 descendants of its own
- 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

## Indications for use
Claritag is indicated for use in the treatment of achrochordons (skin tags).

Source page: https://510kreport.com/device/K190747
Methodology: https://510kreport.com/methodology