# K222356: Claritag Advanced

- Pathway: 510(k) (Traditional)
- Applicant: Dgi Technologies
- Decided: May 18, 2023 after 287 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 5.
- K190747: Claritag, Dgi Technologies (2019) Summary page 7.

## Indications for use
The Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 years or older.

Source page: https://510kreport.com/device/K222356
Methodology: https://510kreport.com/methodology