# K201740: Hydrozid

- Pathway: 510(k) (Traditional)
- Applicant: Medilink A/S
- Decided: Jul 7, 2021 after 377 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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
- K221897: Hydrozid Precise (2023), 0 descendants of its own

## Indications for use
Hydrozid (also known as R134A or 1,1,1,2-tetrafluoroethane or HFC-134a or HFA-134a or fluorocarbon 134a) is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

Source page: https://510kreport.com/device/K201740
Methodology: https://510kreport.com/methodology