# K982506: Verruca-Freeze Cryosurgery Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Cryosurgery, Inc.
- Decided: Jan 27, 1999 after 191 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
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K130995: Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray (2013), 16 descendants of its own
- K161296: Cool Renewal (2016), 12 descendants of its own
- K190747: Claritag (2019), 9 descendants of its own
- 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

## Indications for use
1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratoses, achrochordon, molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, lentigo maligna, keratoacanthoma, basal cell, bowen’s disease, lentigo discreta, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, kaposi’s sarcoma, and pyogenic granuloma.

Source page: https://510kreport.com/device/K982506
Methodology: https://510kreport.com/methodology