# K252903: Verruca-Freeze H Plus

- Pathway: 510(k) (Special)
- Applicant: Cryosurgery, Inc.
- Decided: Oct 10, 2025 after 29 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 K990877 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243454: Verruca-Freeze H, Cryosurgery, Inc. (2024) Summary page 5.
- K130995: Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray, Nuance Medical, LLC (2013) Summary page 5.

## Indications for use
The Verruca-Freeze H Plus cryosurgical system is intended for use by trained medical professionals to treat the following benign skin lesions: - Actinic Keratosis - Genital Warts - Lentigo - Molluscum Contagiosum - Seborrheic Keratosis - Skin Tags - Verruca Plantaris - Verruca Vulgaris - Verruca Plana

Source page: https://510kreport.com/device/K252903
Methodology: https://510kreport.com/methodology