# K130995: Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray

- Pathway: 510(k) (Traditional)
- Applicant: Nuance Medical, LLC
- Decided: Jun 14, 2013 after 65 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: 1 generation back to K881349 (1988). 3 ancestors in all.
16 later devices descend from it; 4 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)
- K982506: Verruca-Freeze Cryosurgery Delivery System, Cryosurgery, Inc. (1999) Summary page 1.
- K881349: Verruca-Freeze (TM) Cryotherapy Delivery System, Cryosurg, Inc. (1988) Summary page 1.
- K944221: Verruca-Freeze (TM) Cryosurgical Delivery Syst, Modified, Cryosurgery, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K243487: CryoFreeze Wart and Skin Tag 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 keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

Source page: https://510kreport.com/device/K130995
Methodology: https://510kreport.com/methodology